|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P130024 / PAS001 |
Date Original Protocol Accepted |
10/09/2014
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Date Current Protocol Accepted |
11/28/2017
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Study Name |
PAS 1 (Extended Follow-up Study)
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Device Name |
LUTONIX DRUG COATED BALLOON PTA CATETER
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Historical Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
Prospective cohort study, continued follow-up of premarket cohorts and LEVANT 2 Safety Registry subjects
|
Study Population |
Patients treated with the Lutonix DCB for stenosis of the femoropopliteal artery
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Sample Size |
657 DCB subjects from the LEVANT 2 Safety Registry 372 DCB subjects from the LEVANT 2 Pivotal IDE study 160 PTA controls from the LEVANT 2 Pivotal IDE study The assumption is that results at 2 years will be proportionally similar in DCB subjects and controls to what they were in the pivotal IDE study. The PAS study will have a much larger sample size and therefor greater power than that of the pivotal IDE study.
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Key Study Endpoints |
Primary effectiveness: Primary patency of the target lesion at 24 months Primary safety: Composite freedom for all cause perioperative (within 30 days), index limb amputation (2 years), index limb re-intervention (2 years), and index limbrelated death (2 years) Secondary endpoints: Individual components of the primary safety endpoint, device- and drug-related adverse events, all-cause death, major vascular complications, target lesion revascularization, and Rutherford classification
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Follow-up Visits and Length of Follow-up |
5 years Clinical follow-up, including Duplex Ultrasound (DUS) will be done at 6 months, 12 months, and 24 months. Telephone f/u will be done at 1 month, 3, 4, and 5 years.
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
Actual number of subjects enrolled: DCB Subjects (1029) Control Subjects (160) This includes: LEVANT 2 Safety Registry patients (n=657), LEVANT 2 randomized DCB (n=316) and LEVANT 2 randomized roll-in (n=56) compared against the results from the LEVANT 2 randomized control PTA (n=160).
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Actual Number of Sites Enrolled |
74
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Patient Follow-up Rate |
DCB Subjects 86% (143/1029) Control Subjects 84% (26/160) Lost to follow up plus withdrew from study.
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Final Safety Findings |
The composite of freedom from all-cause perioperative death (= 30 days) and index limb amputation (including above or below the knee), index limb reintervention, or index limb related death through 24 months was 74.7% (674/902) for the DCB group and 67.1% (94/140) for the PTA group. The DCB group has a higher freedom from the composite safety endpoint rate of 6.4% through the 24 months follow-up.
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Final Effect Findings |
Primary patency of the target lesion at 24 months was 54.5% (458/841) for the DCB group and 47.2% (60/127) for the control group. The DCB group demonstrated a higher rate of primary patency, approximately 6.4%, over the PTA group throughout 24 months.
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Study Strengths & Weaknesses |
The strengths of the study include randomization against an appropriate control and adequate and extended follow up. Study weaknesses include increase mortality for the test device versus control after two years in the randomized patients
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Recommendations for Labeling Changes |
yes
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