At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 252 enrolled
Drug / intervention
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters +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.
EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
In Brief
A Phase 3 clinical trial evaluating Turbo Elite Laser and Turbo Tandem Laser Guide Catheters and Balloon angioplasty for Peripheral Arterial Disease. Completed, enrolled 252 participants across 34 sites in 2 countries.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartJun 2011
Primary CompletionMar 2014
Study CompletionMay 2015
TodayJul 2026
First PostedApr 7, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.2 years ago
Interventions
Turbo Elite Laser and Turbo Tandem Laser Guide Cathetersdevice
application of laser energy to remove blockage followed by standard balloon angioplasty
Balloon angioplastyprocedure
standard balloon catheters for PTA