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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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MIMICS-2 Continued f/u Study


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General
Study Status Study Pending
Application Number P180003 / PAS001
Date Current Protocol Accepted  
Study Name MIMICS-2 Continued f/u Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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).
Study Population Description 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.
Sample Size All 249 remaining subjects (22 subjects have discontinued the study) of the 271 original study subjects enrolled from 43 investigational sites.
Data Collection 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.

Follow-up Visits and Length of Follow-up 36 months


MIMICS-2 Continued f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/02/2019 05/02/2019 On Time
one year report 10/04/2019    
18 month report 04/03/2020    
two year report 10/03/2020    
three year report 10/03/2021    
four year report 10/03/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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