At a glance
ClinicalIndex Comparison RecordN/ACompleted· 446 enrolled
Drug / intervention
Surmodics SurVeil DCB +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 Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB
In Brief
A clinical study evaluating Surmodics SurVeil DCB and Medtronic IN.PACT Admiral DCB for Peripheral Arterial Disease and 3 related conditions. Completed, enrolled 446 participants across 63 sites in 9 countries.
Detailed Summary
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
CountriesAustralia, Austria, Belgium, Czechia, Germany, Italy, Latvia, New Zealand, United States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartOct 2017
Primary CompletionSep 2020
Study CompletionSep 2024
TodayJul 2026
First PostedAug 7, 2017
Enrollment StartOct 23, 2017
Primary CompletionSep 15, 2020
Study CompletionSep 17, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.9 years ago
Interventions
Surmodics SurVeil DCBdevice
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Medtronic IN.PACT Admiral DCBdevice
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.