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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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BOLSTER Continued f/u Study


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General
Study Status Completed
Application Number P160024 / PAS001
Study Name BOLSTER 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 (BOLSTER Continued Follow-Up Study) is to evaluate the long term safety and effectiveness of the LifeStream Balloon Expandable Vascular Covered Stent for treatment of iliac arterial occlusive disease. This study is a prospective, single-armed, multi-center follow-up of the BPV-12-001 pivotal study (G140138).
Study Population Description The study population included symptomatic (Rutherford Category 2-4) patients with angiographic confirmation of either de novo or restenotic (non-stented) common and/or external iliac artery stenoses or occlusions, with reference vessel diameters between 4.5mm and 12.0mm in diameter and the target lesion = 100 mm in combined length (per side). Patients were included who presented with evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion(s) in the native common and/or external iliac artery.
Sample Size All 148 remaining subjects (7 subjects have discontinued the study) of the 155 original study subjects enrolled from 24 investigational sites.
Data Collection Primary Endpoint:

Freedom from target lesion revascularization at 36 months.

Target lesion revascularization 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:

Freedom from target vessel revascularization (TVR) at 12, 24 and 36 months

Freedom from target lesion revascularization (TLR) at 12 and 24 months

Primary patency at 12, 24 and 36 months

Primary assisted patency at 12, 24 and 36 months

Secondary patency at 12, 24 and 36 months

Sustained clinical success at 12, 24 and 36 months

Quality of life at 12, 24 and 36 months

Serious adverse events at 12, 24 and 36 months

Follow-up Visits and Length of Follow-up 36 months
Interim or Final Data Summary
Actual Number of Patients Enrolled 155 subjects were treated with the study device and included in the Intent to treat population; 148 subjects were available at 9 months for the continued PAS.
Actual Number of Sites Enrolled Twenty-four (24) sites were enrolled world-wide. Of these, 17 sites enrolled subjects
Patient Follow-up Rate 87.0% (107/123) at 36 months post index procedure
Final Safety Findings Primary Endpoint

The IDE study met the composite primary safety and effectiveness endpoint defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any target lesion revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.

The proportion of subjects with the composite primary event rate was 11.6% (16/138), 93.5% confidence interval (CI) of 7.0%, 17.8% compared to the performance goal of 19.5%, p= 0.0095 (p-value is less than 0.0325).

The primary endpoint for the continued follow-up study is freedom from target lesion revascularization (TLR) at 36 months. TLR is defined as the first revascularization procedure of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab.

The proportion of subjects with TLR through the 36-month visit was 17.6% (23/131) [95% CI: 11.5%, 25.2%).

Secondary Endpoints Results

The proportion of subjects with target vessel revascularization through 36-month visit was 17.6% (23/131) [95% CI: 11.5%, 25.2%].

The proportion of subjects with primary patency at 36-month visit was 68.6% (72/105)

[95% CI: 58.8%, 77.3%].

The proportion of subjects with primary assisted patency through 36-month visit was 78.8% (78/ 99) [95% CI: 69.4%, 86.4%].

The proportion of subjects with secondary patency through the 36- month visit was 86.8% (79/91) [95%

CI: 78.1%, 93.0%].

The proportion of subjects with sustained clinical success at the 36-month visit was 92.5% (98/106)

[95% CI: 85.7%, 96.7%].

The proportion of subjects with any serious adverse events was 63.9% (99/155).
Study Strengths & Weaknesses Strengths: The IDE study was a single-arm, prospective multicenter study conducted in the United States

and OUS countries. The study met its composite primary safety and effectiveness primary endpoint. The

PAS was a continued follow-up of the premarket subjects through 36 months, with a 36-month followup

rate of 87%.

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. The

results of the post-approval study were analyzed by descriptive analysis only.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term results of the post-approval study. The

labeling change should include a new section on the label showing a summary of the post-approval

study methods (including study objectives, design, population, number of enrolled sites/subjects, key

endpoints, follow-up visits etc.), final results, strengths and limitations of the PAS.


BOLSTER Continued f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/23/2017 10/24/2017 Overdue/Received
one year report 04/24/2018 04/20/2018 On Time
final report 02/28/2019 02/28/2019 On Time


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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