Iliac Artery Stenosis Clinical Trial
— ORIONOfficial title:
A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Verified date | April 2015 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.
Status | Completed |
Enrollment | 125 |
Est. completion date | December 2013 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4) - Lifestyle-limiting claudication or rest pain - De novo or restenotic lesions in the common and/or external iliac artery - Subjects with bilateral disease may have only one target lesion treated per side - Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent) - Length of diseased segment(s) <=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents - Baseline diameter stenosis >= 50% (operator visual assessment) - Reference vessel diameter >= 5 mm and <=11 mm - At least one sufficient ipsilateral infrapopliteal run-off vessel - Origin of profunda femoris artery is patent Exclusion Criteria: - Target vessel with in-stent restenosis - Acute critical limb ischemia - Tissue loss (Rutherford/Becker category 5 or 6) - Any major amputations to the target limb - Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed. - Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial - Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. - Intolerance to antiplatelet, anticoagulant, or thrombolytic medications - Platelet count < 150,000 mm3 or > 600,000 mm3 - Serum creatinine > 2.0 mg/dL - Dialysis-dependent end stage renal disease - Pregnancy - Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial - Known allergy to Nitinol - Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel - Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography - Target lesion is within or near an aneurysm - Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy - Perforated vessel as evidenced by extravasation of contrast media - Vascular graft, aneurysm or postsurgical stenosis of the target vessel - Multiple lesions in the same target vessel unable to be treated with a maximum of two stents |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Brandon Regional Hospital | Brandon | Florida |
United States | Fletcher Allen Health Care | Burlington | Vermont |
United States | Mid-Carolina Cardiology - Presbyterian Hospital | Charlotte | North Carolina |
United States | Erlanger Medical Center | Chattanooga | Tennessee |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | VA North Texas Health Care System | Dallas | Texas |
United States | Trinity Terrace Park | Davenport | Iowa |
United States | MeritCare Hospital | Fargo | North Dakota |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Parkview Hospital-Parkview Research Center | Fort Wayne | Indiana |
United States | St. Vincent's Hospital | Indianapolis | Indiana |
United States | Wellstar Kennestone Hospital | Marietta | Georgia |
United States | St. Thomas Research Institute | Nashville | Tennessee |
United States | Mount Sinai Medical Center | New York | New York |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | Mediquest Research at Munroe Regional Medical Center | Ocala | Florida |
United States | University of Oklahoma Health Science Center | Oklahoma City | Oklahoma |
United States | UPMC - Shadyside Hospital | Pittsburgh | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Wake Medical Center | Raleigh | North Carolina |
United States | North Memorial Medical Center | Robbinsdale | Minnesota |
United States | Baptist Hospital of San Antonio | San Antonio | Texas |
United States | St. Joseph's Hospital | Tucson | Arizona |
United States | York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device- and/or Procedure-related Major Adverse Events (MAE) | MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months | 9 Months | Yes |
Secondary | Death | Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions | 30 Days | Yes |
Secondary | Death | Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions | 9 Months | Yes |
Secondary | Death | Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions | 1 Year | Yes |
Secondary | Death | Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions | 2 Years | Yes |
Secondary | Death | Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions | 3 Years | Yes |
Secondary | Amputation of Index Limb | Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes | 9 Months | Yes |
Secondary | Amputation of Index Limb | Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes | 1 Year | Yes |
Secondary | Amputation of Index Limb | Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes | 2 Years | Yes |
Secondary | Amputation of Index Limb | Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes | 3 Years | Yes |
Secondary | Target Vessel Revascularization (TVR) | Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. |
30 Days | No |
Secondary | Target Vessel Revascularization (TVR) | Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. |
9 Months | No |
Secondary | Target Vessel Revascularization (TVR) | Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. |
1 Year | No |
Secondary | Target Vessel Revascularization (TVR) | Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. |
2 Years | No |
Secondary | Target Vessel Revascularization (TVR) | Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. |
3 Years | No |
Secondary | Myocardial Infarction (MI) | Definition of myocardial infarction: New Q-waves in =2 leads lasting =0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications. | Index hospitalization | Yes |
Secondary | Technical Success | Residual lesion stenosis <=30% based on visual assessment immediately postprocedure | Index procedure | No |
Secondary | Procedure Success | Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb). | In hospital (1-2 days post procedure) | Yes |
Secondary | Early Clinical Success | Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
Hospital Discharge | No |
Secondary | Early Clinical Success | Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
30 Days | No |
Secondary | Late Clinical Success | Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
9 Months | No |
Secondary | Late Clinical Success | Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
1 Year | No |
Secondary | Early Hemodynamic Success | Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb. | Hospital Discharge | No |
Secondary | Early Hemodynamic Success | Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb. | 30 Days | No |
Secondary | Late Hemodynamic Success | Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb. | 9 Months | No |
Secondary | Late Hemodynamic Success | Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb. | 1 Year | No |
Secondary | Rutherford Classification Distribution | Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic = Mild claudication = Moderate claudication = Severe claudication = Ischemic rest pain = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
Pre-procedure/baseline | No |
Secondary | Rutherford Classification Distribution | Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic = Mild claudication = Moderate claudication = Severe claudication = Ischemic rest pain = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
Post-procedure | No |
Secondary | Rutherford Classification Distribution | Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic = Mild claudication = Moderate claudication = Severe claudication = Ischemic rest pain = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema |
30 Days | No |
Secondary | Rutherford Classification Distribution | Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss |
9 Months | No |
Secondary | Rutherford Classification Distribution | Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss |
1 Year | No |
Secondary | Acute Stent Thrombosis | Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure. |
24 Hours | Yes |
Secondary | Sub-acute Stent Thrombosis | Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure. |
>24 Hours to <=30 Days Post-index procedure | Yes |
Secondary | Stent Thrombosis | Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Late stent thrombosis is defined as >30 days to 365 days following the trial procedure. |
9 Months | Yes |
Secondary | Stent Thrombosis | Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Late stent thrombosis is defined as >30 days to 365 days following the trial procedure. |
1 Year | Yes |
Secondary | Stent Thrombosis | Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Very late stent thrombosis is defined as >365 days following the trial procedure. |
2 Years | Yes |
Secondary | Stent Thrombosis | Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Very late stent thrombosis is defined as >365 days following the trial procedure. |
3 Years | Yes |
Secondary | Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. | 30 Days | No |
Secondary | Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. | 9 Months | No |
Secondary | Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. | 1 Year | No |
Secondary | Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. | 2 Years | No |
Secondary | Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia. | 3 Years | No |
Secondary | Ankle-Brachial Index (ABI) | Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation. |
Pre-procedure/baseline | No |
Secondary | Ankle-Brachial Index | Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation. |
Hospital Discharge (1-2 days post-procedure) | No |
Secondary | Ankle-Brachial Index (ABI) | Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation. |
30 Days | No |
Secondary | Ankle-Brachial Index (ABI) | Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation. |
9 Months | No |
Secondary | Ankle-Brachial Index (ABI) | Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation. |
1 Year | No |
Secondary | Primary Patency | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization, bypass of the target lesion, or amputation. | 9 Months | No |
Secondary | Primary Patency | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization, bypass of the target lesion, or amputation. | 1 Year | No |
Secondary | Primary-assisted Patency (PAP) | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis. | 9 Months | No |
Secondary | Primary-assisted Patency (PAP) | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis. | 1 Year | No |
Secondary | Secondary Patency | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR =2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis. | 9 Months | No |
Secondary | Secondary Patency | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR =2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis. | 1 Year | No |
Secondary | Restenosis Assessed by Duplex Ultrasound | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis. | 9 Months | No |
Secondary | Restenosis Assessed by Duplex Ultrasound | Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis. | 1 Year | No |
Secondary | Walking Impairment Questionnaire Score - Distance | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | Pre-procedure/baseline | No |
Secondary | Walking Impairment Questionnaire Score - Distance | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | 9 Months | No |
Secondary | Walking Impairment Questionnaire Score - Distance | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | 1 Year | No |
Secondary | Walking Impairment Questionnaire Score - Speed | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | Pre-procedure/baseline | No |
Secondary | Walking Impairment Questionnaire Score - Speed | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | 9 Months | No |
Secondary | Walking Impairment Questionnaire Score - Speed | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | 1 Year | No |
Secondary | Walking Impairment Questionnaire Score-Stair Climbing | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | Pre-procedure/baseline | No |
Secondary | Walking Impairment Questionnaire Score - Stair Climbing | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | 9 Months | No |
Secondary | Walking Impairment Questionnaire Score - Stair Climbing | The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. | 1 Year | No |
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