At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 enrolled
Drug / intervention
paclitaxel coated balloon catheterdevice
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.
P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses: A Comparison to the Paclitaxel-Eluting Taxus™ Stent. A Pilot Study
In Brief
A Phase 2 clinical trial evaluating paclitaxel coated balloon catheter for In-Stent Restenosis. Completed, enrolled 120 participants across 10 sites.
Detailed Summary
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with reference diameters between 2.5 mm and 3.5 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency in comparison to the Paclitaxel-eluting Taxus™ stent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIn-Stent Restenosis
CountriesGermany
CollaboratorsB. Braun Melsungen AG
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedOct 2006
Primary CompletionDec 2006
Study CompletionDec 2007
TodayJul 2026
First PostedOct 27, 2006
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2006
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.7 years ago
Interventions
paclitaxel coated balloon catheterdevice