Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: BioMimics 3D Vascular Stent System
- Registration Number
- NCT02400905
- Lead Sponsor
- Veryan Medical Ltd.
- Brief Summary
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.
- Detailed Description
The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility criteria may be considered for enrollment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 271
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BioMimics 3D Vascular Stent BioMimics 3D Vascular Stent System Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE) 30 days Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.
Primary Effectiveness Endpoint (Primary Stent Patency Rate) 12 months The primary effectiveness endpoint of the MIMICS-2 Study was defined as the primary stent patency rate at 12 months. Patency was defined as no significant reduction in luminal diameter (\< 50% diameter stenosis) since the index procedure. Loss of patency was determined by an independent core laboratory when the peak systolic velocity ratio (PSVR) exceeds 2.0, or where angiography revealed \> 50% diameter stenosis, or where the subject had a CDTLR.
- Secondary Outcome Measures
Name Time Method Clinical Outcome (Six-Minute Walk Test) Baseline, Day 30, Months 12 & 24 Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).
Number of Participants With Serious Adverse Events 36 Months Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.
Long Term Safety (Overall MAE Rate at Month 12) 12 months Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More Baseline, Day 30, Months 12 & 24 Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.
Categories 0 - Asymptomatic
1. - Mild claudication
2. - Moderate claudication
3. - Severe claudication
4. - Ischemic rest pain
5. - Minor tissue loss
6. - Major tissue lossFunctional Outcome (Ankle Brachial Index (ABI) Measurement) Baseline, Day 30, Months 12 & 24 Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.
Number of Participants With Freedom From Stent Fracture Months 12, 24 & 36 Stent integrity measured as freedom from fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays taken with the leg in extension at 12, 24 and 36 Months.
Secondary Safety (Overall MAE Rate at 30 Days) 30 Days Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.
Technical Success Procedural (at end of index procedure) Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure
Primary Stent Patency Months 12 & 24 Determined at Months-12 and 24 using values of: PSVR \>2.0, \>2.4; \>2.5; and \>3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals \>50% diameter stenosis or where the subject undergoes clinically-driven TLR.
Further analysis of the patency data purely using a reference PSVR of \>2.4, \>2.5 and \>3.5 was not feasible from the data that was collected.Change of Walking Impairment Questionnaire Score Baseline, Day 30, Months 12 & 24 Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.
The WIQ consists of 3 primary categories assessing walking distance, stair-climbing, and walking speed, as previously described. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none).
Trial Locations
- Locations (42)
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
MediQuest Research Group/ Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
Coastal Vascular
🇺🇸Pensacola, Florida, United States
Kings Daughters Medical Center
🇺🇸Ashland, Kentucky, United States
Endovascular Technologies / Grace Research
🇺🇸Bossier City, Louisiana, United States
Michigan Vascular Center
🇺🇸Flint, Michigan, United States
Deborah Heart & Lung Center
🇺🇸Browns Mills, New Jersey, United States
NC Heart & Vascular Research
🇺🇸Raleigh, North Carolina, United States
Berks Cardiologists
🇺🇸Wyomissing, Pennsylvania, United States
Austin Heart Research
🇺🇸Austin, Texas, United States
Mission Research Institute/Guadalupe Regional Medical Center
🇺🇸New Braunfels, Texas, United States
Grace Research
🇺🇸Huntsville, Texas, United States
Cardiovascular Associates of East Texas
🇺🇸Tyler, Texas, United States
Karolinen-Hospital
🇩🇪Arnsberg, Germany
Universitaets-Herzzentrum Freiburg-Bad Krozingen
🇩🇪Bad Krozingen, Germany
Westküstenklinikum Heide
🇩🇪Heide, Germany
Diakonissenkrankenhaus Flensburg
🇩🇪Flensburg, Germany
Universitätsklinikum Leipzig AoR Leipzig
🇩🇪Leipzig, Germany
St. Bonifatius Hospital
🇩🇪Lingen, Germany
Kansai Rosai Hospital
🇯🇵Hyogo, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu-shi, Japan
Kasukabe Chuo General Hospital
🇯🇵Kasukabe, Japan
Morinomiya Hospital
🇯🇵Osaka, Japan
Cardiology Associates of Mobile
🇺🇸Mobile, Alabama, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
WakeMed Research
🇺🇸Raleigh, North Carolina, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Pinnacle Health Harrisburg
🇺🇸Harrisburg, Pennsylvania, United States
Cardiovascular Specialist of TX / North Austin Medical Center
🇺🇸Austin, Texas, United States
Minneapolis Heart
🇺🇸Minneapolis, Minnesota, United States
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Michigan Outpatient Vascular Institute
🇺🇸Dearborn, Michigan, United States
Bradenton Cardiology Center
🇺🇸Bradenton, Florida, United States
Omihachiman Community Medical Center
🇯🇵Shiga, Japan
Kore Cardiovascular Research
🇺🇸Jackson, Tennessee, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Toho University Ohashi Medical Center
🇯🇵Tokyo, Japan
St. John Hospital & Medical Center
🇺🇸Detroit, Michigan, United States
Cardiovascular Institute of the South
🇺🇸Lafayette, Louisiana, United States
North Central Heart
🇺🇸Sioux Falls, South Dakota, United States