At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 87 enrolled
Drug / intervention
paclitaxel coated balloon catheter (device with drug)device
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.
Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)
In Brief
A Phase 2 clinical trial evaluating paclitaxel coated balloon catheter (device with drug) for Peripheral Arterial Disease. Completed, enrolled 87 participants across 2 sites.
Detailed Summary
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2004
First PostedMay 2007
Primary CompletionJul 2007
TodayJul 2026
First PostedMay 11, 2007
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.1 years ago
Interventions
paclitaxel coated balloon catheter (device with drug)device
PTA vs Paccocath