At a glance
ClinicalIndex Comparison RecordPhase 4Unknown· 70 target
Drug / intervention
PTA +2 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.
Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)
In Brief
A Phase 4 clinical trial evaluating PTA, PTA with PEB, and 1 other intervention for Peripheral Vascular Disease. Targeting 70 participants across 2 sites.
Detailed Summary
The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Disease
CountriesGermany
Collaborators--
Timeline
Phase 4UnknownOverdue
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionDec 2014
Study CompletionDec 2015
TodayJul 2026
First PostedMar 9, 2010
Enrollment StartMar 1, 2010
Primary CompletionDec 1, 2014
Study CompletionDec 1, 2015
TodayJul 1, 2026
Enrollment to primary: 4.8 yearsPosted 16.3 years ago
Interventions
PTAdevice
PTA using a conventional balloon
PTA with PEBdevice
PTA using a paclitaxel eluting balloon
Percutaneous Transluminal Angioplasty (PTA)procedure
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon