CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,189 enrolled
Drug / intervention
Lutonix Drug Coated Balloon +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.

Search/NCT01790243
NCT01790243N/ACompleted
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A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)

C. R. Bard·interventional·Posted Feb 13, 2013·Updated Jun 5, 2020

In Brief

A clinical study evaluating Lutonix Drug Coated Balloon and Standard PTA Balloon for Peripheral Artery Disease and 2 related conditions. Completed, enrolled 1,189 participants across 8 sites.

Detailed Summary

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2013
Enrollment StartJul 20, 2011
Primary CompletionNov 27, 2015
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.4 years ago

Interventions

Lutonix Drug Coated Balloondevice

Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.

Standard PTA Balloondevice

Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.