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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160024 / PAS001 |
| Study Name |
BOLSTER Continued f/u Study
|
| Device Name |
LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
|
| 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
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| Detailed Study Protocol Parameters |
| Study Objectives |
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 |
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.
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| Sample Size |
All 148 remaining subjects (7 subjects have discontinued the study) of the 155 original study subjects enrolled from 24 investigational sites.
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| Key Study Endpoints |
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).
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| 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.
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| 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.
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