N/A
Completed N=271
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
Source: ClinicalTrials.gov NCT02400905 ↗Enrolled (actual)
271
Serious AEs
60.5%
Results posted
Jan 2019
Primary outcomePrimary: Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE) — 268 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE) |
268 | — |
| PRIMARY Primary Effectiveness Endpoint (Primary Stent Patency Rate) |
182 | — |
| SECONDARY Secondary Safety (Overall MAE Rate at 30 Days) |
269; 269; 268 | — |
| SECONDARY Long Term Safety (Overall MAE Rate at Month 12) |
226; 257; 258; 227 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
271; 13; 26; 114; 146; 164 | — |
| SECONDARY Technical Success |
269 | — |
| SECONDARY Primary Stent Patency |
— | — |
| SECONDARY Number of Participants With Improvement of Rutherford Clinical Category by 1 or More |
233; 216; 195 | — |
| SECONDARY Clinical Outcome (Six-Minute Walk Test) |
230; 349; 278; 405 | — |
| SECONDARY Functional Outcome (Ankle Brachial Index (ABI) Measurement) |
0.70; 0.98; 0.92; 0.94 | — |
| SECONDARY Change of Walking Impairment Questionnaire Score |
0.28; 0.58; 0.58; 0.56 | — |
| SECONDARY Number of Participants With Freedom From Stent Fracture |
229; 204; 102 | — |
Eligibility Criteria
Inclusion Criteria
- 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 ( 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.
Data sourced from ClinicalTrials.gov (NCT02400905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.