At a glance
ClinicalIndex Comparison RecordN/ACompleted· 82 enrolled
Drug / intervention
Lutonix DCB +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
In Brief
A clinical study evaluating Lutonix DCB and Standard Uncoated Balloon Angioplasty Catheter for Femoral Artery Stenosis and 2 related conditions. Completed, enrolled 82 participants across 20 sites.
Detailed Summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionFeb 2017
Study CompletionMar 2019
TodayJul 2026
First PostedFeb 14, 2014
Enrollment StartMar 1, 2014
Primary CompletionFeb 13, 2017
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.4 years ago
Interventions
Lutonix DCBdevice
Standard Uncoated Balloon Angioplasty Catheterdevice
PTA Catheter