At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 85 enrolled
Drug / intervention
Drug Eluting Balloon Angioplasty +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.
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
In Brief
A Phase 4 clinical trial evaluating Drug Eluting Balloon Angioplasty and Nitinol stenting for Peripheral Arterial Disease and 8 related conditions. Completed, enrolled 85 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases, Paclitaxel, Plaque, Atherosclerotic, Critical Limb Ischemia
CountriesBrazil
CollaboratorsMedtronic
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedAug 2014
Primary CompletionDec 2018
Study CompletionOct 2019
TodayJul 2026
First PostedAug 8, 2014
Enrollment StartJul 1, 2014
Primary CompletionDec 1, 2018
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.9 years ago
Interventions
Drug Eluting Balloon Angioplastydevice
Angioplasty with Drug eluting balloon after pre dilatation
Nitinol stentingdevice
Nitinol stent deployment