Atherosclerosis of Native Arteries of the Extremities, Unspecified Clinical Trial
Official title:
Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
| Status | Active, not recruiting |
| Enrollment | 299 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Subjects age 18 and older 2. Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 3. Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery: 1. Degree of stenosis >/=70% by visual angiographic assessment 2. Vessel diameter >/= 4 and </= 7mm 3. Total lesion length (or series of lesions) >/=30mm and </= 190 mm (note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent) 4. If lesion is restenotic, PTA treatment must be >3 months prior to stent placement 5. Target lesion located at least three centimeters above the inferior edge of the femur 4. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot 5. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits Exclusion Criteria: 1. Previous stent placement in the target vessel 2. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease 3. Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months 4. Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure 5. History of major amputation in the same limb as the target lesion 6. Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study 7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. 8. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications 9. Platelet count <150,000 mm3 or >600,000 mm3 10. Concomitant renal failure with a serum creatinine >2.0 mg/dL 11. Receiving dialysis or immunosuppressant therapy 12. Pregnancy 13. Current participation in another investigational drug or device clinical study 14. Known allergy to Nitinol 15. Septicemia at the time of the index procedure 16. Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure 17. Target lesion is within or near an aneurysm 18. Acute ischemia and/or acute thrombosis of the SFA/PPA 19. Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy 20. Perforated vessel as evidenced by extravasation of contrast media 21. Heavily calcified lesions |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Allgemeines Krankenhaus AKH | Vienne | |
| Belgium | Imelda Ziekenhuis | Bonheiden | |
| Belgium | AZ Sint-Blasius, Campus Dendermonde | Dendermonde | |
| Belgium | Ziekenhuis Oost Limburg | Genk | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Regionaal Ziekenhuis Heilig Hart Tienen | Tienen | |
| Canada | Guelph General Hospital | Guelph | |
| Canada | Hospital Maisonneuve-Rosemont | Montreal | |
| Canada | Fleurimont Hospital | Sherbrook | Quebec |
| Canada | Winnipeg Health Sciences Centre | Winnipeg | |
| Germany | Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus | Berlin | |
| Germany | Ev. Luth. Diakonissenanstalt Flensburg | Flensburg | |
| Germany | Herzzentrum Leipzig GmbH/Park Krankenhaus | Leipzig | |
| Germany | Friedrich-Ebert-Krankenhaus Neumuenster GmbH | Neumuenster | |
| Japan | Kansai Rosai Hospital | Amagasaki-shi | Hyogo |
| Japan | Kishiwada Tokushukai Hospital | Kishiwada-shi | Osaka-fu |
| Japan | Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka |
| Japan | Morinomiya Hospital | Osaka | |
| Japan | Tokeidai Memorial Hospital | Sapporo-shi | Hokkaido |
| Japan | Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo |
| United Kingdom | Northern General Hospital | Sheffield | |
| United States | St. Joseph's Hospital of Atlanta | Atlanta | Georgia |
| United States | Frederick Memorial Hospital | Baltimore | Maryland |
| United States | Medical Center East | Birminham | Alabama |
| United States | Willis Knighton Bossier Medical Center | Bossier City | Louisiana |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Fletcher Allen Health Care | Burlington | Vermont |
| United States | Mid-Carolina Cardiology Presbyterian Hospital | Charlotte | North Carolina |
| 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 | Heart Center of Northe Texas | Fort Worth | Texas |
| United States | Parkview Hospital | Ft. Wayne | Indiana |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | St. Joseph's Hospital Health Center | Liverpool | New York |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Methodist North Hospital | Memphis | Tennessee |
| United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | St. Thomas Research Institute, LLC | Nashville | Tennessee |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
| United States | St. Francis Medical Center | Peoria | Illinois |
| United States | Northern Michigan Hospital | Petoskey | Michigan |
| United States | UPMC - Passavant | Pittsburgh | Pennsylvania |
| United States | Rex Hospital | Raliegh | North Carolina |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Coastal Surgery Specialists | Wilmington | North Carolina |
| United States | York Hospital | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States, Austria, Belgium, Canada, Germany, Japan, United Kingdom,
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Technical and Procedural Success | Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% Procedural success: technical success with no MAEs within 24 hours of the procedure |
Up to 24 hours after the procedure | No |
| Other | Primary Patency | Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion. | 12 months | No |
| Other | Assisted Primary Patency | Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis. | 12 months | No |
| Other | Stent Fracture Rate | Vascular InterVentional Advances (VIVA) definitions: Grade 0: No strut fractures Grade I: single strut fracture Grade II: multiple strut fractures Grade III: stent fracture(s) with preserved alignment of the components Grade IV: stent fracture(s) with mal-alignment of the components Grade V: stent fracture(s) in a trans-axial spiral configuration |
12 months | Yes |
| Other | Rutherford Classification | 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 - nonhealing ulcer, focal gangrene with diffuse pedal edema Class 6: Major tissue loss - extending above metatarsal (MT) level Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure |
12 months | No |
| Other | Rate of Hemodynamic Improvement | The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. Hemodynamic Improvement: Increases in ABI of = 0.10 or to an ABI = 0.90 as compared to pre-procedure without the need for repeat TLR. Hemodynamic Improvement (Including TLR): Increases in ABI of =0.10 or to an ABI =0.90 as compared to pre-procedure including TLR. |
12 months | No |
| Other | Walking Improvement Assessed by the Walking Impairment Questionnaire | The Walking Impairment Questionnaire (WIQ) is a validated 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. | 12 months | No |
| Other | Walking Improvement (Time) Assessed by 6 Minute Hall Walk | Assessment of walking improvement by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes. | 12 months | No |
| Other | Quality of Life | Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning. | 12 months | No |
| Other | Walking Improvement (Distance) Assessed by 6 Minute Hall Walk | Assessment of walking improvement by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes. | 12 months | No |
| Primary | Primary Safety Endpoint and Components | The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months | 1 month for death, 12 months for target limb major amputation , and target lesion revascularization | Yes |
| Primary | Co-Primary Efficacy Endpoints | The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm). |
12 months | No |
| Secondary | Secondary Safety Endpoint and Components | The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month | 1 month | Yes |