At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 101 enrolled
Drug / intervention
Lutonix Catheter +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 Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.
In Brief
A Phase 2 clinical trial evaluating Lutonix Catheter and Standard uncoated Balloon Angioplasty Catheter for Atherosclerosis and 2 related conditions. Completed, enrolled 101 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis, Vascular Disease, Arteriosclerosis
CountriesBelgium, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJul 2009
Primary CompletionJun 2010
Study CompletionDec 2011
TodayJul 2026
First PostedJul 2, 2009
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17 years ago
Interventions
Lutonix Catheterdevice
Paclitaxel Coated Balloon Catheter
Standard uncoated Balloon Angioplasty Catheterdevice
plain, uncoated angioplasty balloon catheter