Peripheral Arterial Disease Clinical Trial
Official title:
A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients With Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries
NCT number | NCT02733653 |
Other study ID # | S6051 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2016 |
Est. completion date | December 20, 2017 |
Verified date | December 2018 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal arteries (PPA).
Status | Completed |
Enrollment | 60 |
Est. completion date | December 20, 2017 |
Est. primary completion date | June 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4 - Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet all of the following criteria: - Calcified lesions with degree of stenosis =70% or occlusions - Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course - Vessel diameter =3.0 mm and =6.0 mm - Total lesion length (or series of lesions) =150mm - Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate - Patent infrapopliteal and popliteal artery Exclusion Criteria: - Target lesion/vessel with in-stent restenosis - Target lesion/vessel previously treated with drug-coated balloon <12 months prior to the procedure - Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure - Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure - Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure - History of major amputation in the target limb - Subject has a history of coagulopathy or hypercoagulable bleeding disorder - Subject with untreatable hemorrhagic disease or platelet count <80,000mm3 or >600,000mm3 as baseline assessment. - Concomitant renal failure with a serum creatinine >2.0 mg/dL - Receiving dialysis or immunosuppressant therapy - History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment - Unstable angina pectoris at the time of the enrollment - Septicemia at the time of enrollment - Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure - Presence of aneurysm in the target vessel - Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure - Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure |
Country | Name | City | State |
---|---|---|---|
Japan | Kansai Rosai Hospital | Amagasaki | Hyogo |
Japan | Iwaki Kyouritsu Hospital | Iwaki | Fukushima |
Japan | Kasukabe Chuo General Hospital | Kasukabe | Saitama |
Japan | Kishiwada Tokushukai Hospital | Kishiwada | Osaka |
Japan | Kokura Memorial Hospital | Kokura | Fukuoka |
Japan | Miyazaki Medical Association Hospital | Miyazaki | |
Japan | Nagano Red Cross Hospital | Nagano | |
Japan | Nagoya Kyoritsu Hospital | Nagoya | Aichi |
Japan | Tokeidai Memorial Hospital | Sapporo | Hokkaido |
Japan | Saiseikai Yokohama-City Eastern Hospital | Yokohama | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Procedural Success Rate | Bailout stenting or surgical procedure during the index procedure is not needed | during procedure | |
Other | Rate of Distal Emboli Requiring Additional Treatment | during procedure or within 24 hours post-index procedure | ||
Other | Reduction in Lesion Stenosis | The difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream. | during procedure | |
Other | Major Adverse Event (MAE) Rate | All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 12 months | 1 month, 6 months and 12 months | |
Other | Primary Patency | Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or, bypass of the target lesion. | 1 month, 6 months and 12 months | |
Other | Assisted Primary Patency | Percentage (%) of lesions without TLR and those with TLR (not due to complete occlusion or by-pass) that reach endpoint without restenosis. | 1 month, 6 months and 12 months | |
Other | Clinically-driven TLR Rate | 1 month, 6 months and 12 months | ||
Other | Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 month, 6 months and 12 months | ||
Other | Adverse Event Rates | 1 month, 6 months and 12 months | ||
Other | Distribution of Rutherford Class | Distribution of Rutherford Class as compared to baseline at 6 months and 12 months | 6 months and 12 months | |
Other | Rate of Primary and Secondary Sustained Clinical Improvement | 1 month, 6 months and 12 months | ||
Other | Rate of Hemodynamic Improvement | 1 month, 6 months and 12 months | ||
Primary | Primary Patency Rate | 6 months |
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