At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
Lutonix Paclitaxel-Coated Balloondevice
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, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents
In Brief
A Phase 2 clinical trial evaluating Lutonix Paclitaxel-Coated Balloon for In-Stent Restenosis. Completed, enrolled 41 participants across 8 sites in 3 countries.
Detailed Summary
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIn-Stent Restenosis
CountriesBelgium, Germany, Netherlands
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionOct 2010
Study CompletionDec 2011
TodayJul 2026
First PostedJun 9, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.1 years ago
Interventions
Lutonix Paclitaxel-Coated Balloondevice
PTCA