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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180003 / PAS001 |
| Date Original Protocol Accepted |
10/04/2018
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| Date Current Protocol Accepted |
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| Study Name |
MIMICS-2 Continued f/u Study
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| Device Name |
BioMimics 3D Vascular Stent System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this post approval study (MIMICS-2 Continued Follow-Up Study) is to evaluate the long term safety and effectiveness of the Biomimics 3D Vascular Stent System for the treatment of superficial femoral and/or proximal popliteal occlusive disease. This study is a prospective, multi-center follow-up of the MIMICS-2 pivotal study (G140182).
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| Study Population |
The study population included symptomatic (Rutherford Category 2-4) patients with angiographic confirmation of either de novo superficial femoropopliteal artery stenoses or occlusions, with reference vessel diameters between 4.0mm and 6.0mm in diameter and the target lesion(s) measure =40 mm to =140 mm in overall length.
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| Sample Size |
All 249 remaining subjects (22 subjects have discontinued the study) of the 271 original study subjects enrolled from 43 investigational sites.
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| Key Study Endpoints |
Primary Endpoint:
Freedom from clinically driven target lesion revascularization (CDTLR) at 36 months.
CDTLR is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure as determined by an Independent Angiographic Core Lab (or CEC, as necessary).
Secondary Endpoints:
Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.
Primary stent patency rate: determined at Month 24 per protocol definition of primary stent patency.
Clinical outcome: comparison of Rutherford Clinical Category measured at Baseline and Month 24. Worsening of Rutherford Clinical Category is defined as an increase by one or more categories compared to Baseline or unexpected major amputation of the target limb.
Comparison of Six-Minute Walk Test measured at Baseline and Month 24 (sub-group of investigational sites).
Comparison of the ankle brachial index (ABI) measurement at Baseline and Month 24.
Comparison of the Walking Impairment Questionnaire at Baseline and Month 24.
Stent integrity measured as freedom from stent 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 24 and 36 Months.
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| Follow-up Visits and Length of Follow-up |
36 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
271
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| Actual Number of Sites Enrolled |
43
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| Patient Follow-up Rate |
Of 271 enrolled subjects, 256 completed the 12-month follow-up visit, 225 completed the 24-month follow-up, and 208 completed the 36-month follow-up.
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| Final Safety Findings |
Primary safety (CEC-adjudicated freedom from MAE through 30 days) was 99.6% [97.7% 100%]. The primary safety endpoint was met. In addition, through 36 months, the overall MAE rate was 29.1%, meaning the 36-month freedom from MAE was 70.9%.
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| Final Effect Findings |
Primary effectiveness (primary stent patency at 12 months) was 73.1% [67.3% 78.2%]. The primary effectiveness endpoint was met. In addition, through 24 months, primary stent patency was confirmed in 62.9% of subjects. Patency was not assessed at the 36-month
follow-up unless clinical signs or symptoms suggesting worsening claudication were present.
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| Study Strengths & Weaknesses |
Strengths: The IDE study was a prospective, single-arm multicenter trial in the US and OUS countries.
The IDE study met its primary safety and effectiveness endpoints. The PAS also met its primary endpoint
of having a 36-month rate of freedom from CDTLR greater than the performance goal of 55%.
Weaknesses: This was a single-arm observational study and therefore lacks the inherent advantages of a
randomized control trial. There was no comparator for the continued follow-up study results.
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| Recommendations for Labeling Changes |
To update the summary of clinical data within the Instructions for Use to reflect the complete clinical dataset.
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