Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.

Key facts

Study ID

NCT02400905

Run by

Veryan Medical Ltd.

People needed

271

Starts

2015-06-29

Expected to finish

2019-12-03

Last updated by the study team

2021-06-04

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion of the native femoropopliteal artery.
• PAD classified as Rutherford clinical category 2, 3 or 4.
• Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target limb) or angiographic or DUS evidence of >/= 60%.
• Single or multiple stenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
• Single or multiple target lesions must be covered by a single stent or two overlapping stents.
• Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep femoral artery and at least 3 cm above the bottom of the femur.
• Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm.
• Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with ≥60% diameter stenosis by operator's visual estimate.
• Patent popliteal artery (no stenosis ≥50%) distal to the treated segment.
• At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle.

You may not qualify if…

• Iliac stent in target limb that has required re-intervention within 12 months prior to index.
• Target vessel that has been treated with bypass surgery.
• PAD classified as Rutherford clinical category 0, 1, 5 or 6.
• Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR >1.8.
• Stroke diagnosis within 3 months prior to enrollment.
• History of unstable angina or myocardial infarction within 60 days prior to enrollment.
• Thrombolysis within 72 hours prior to the index procedure.
• Acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on peritoneal or hemodialysis.
• Significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication).
• No patent (≥50% stenosis) outflow vessel providing run-off to the ankle.
• Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent.

Where it is running

• Brookwood Medical Center — Birmingham, Alabama, United States
• Cardiology Associates of Mobile — Mobile, Alabama, United States
• Arizona Heart Hospital — Phoenix, Arizona, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Bradenton Cardiology Center — Bradenton, Florida, United States
• MediQuest Research Group/ Munroe Regional Medical Center — Ocala, Florida, United States
• Coastal Vascular — Pensacola, Florida, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Kings Daughters Medical Center — Ashland, Kentucky, United States
• Endovascular Technologies / Grace Research — Bossier City, Louisiana, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Cardiovascular Institute of the South — Lafayette, Louisiana, United States
• Michigan Outpatient Vascular Institute — Dearborn, Michigan, United States
• St. John Hospital & Medical Center — Detroit, Michigan, United States
• Michigan Vascular Center — Flint, Michigan, United States
• Minneapolis Heart — Minneapolis, Minnesota, United States
• Deborah Heart & Lung Center — Browns Mills, New Jersey, United States
• NC Heart & Vascular Research — Raleigh, North Carolina, United States
• WakeMed Research — Raleigh, North Carolina, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Pinnacle Health Harrisburg — Harrisburg, Pennsylvania, United States
• Berks Cardiologists — Wyomissing, Pennsylvania, United States
• North Central Heart — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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