At a glance
ClinicalIndex Comparison RecordN/ACompleted· 442 enrolled
Drug / intervention
Lutonix 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.
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)
In Brief
A clinical study evaluating Lutonix DCB and Uncoated PTA Catheter for Critical Limb Ischemia. Completed, enrolled 442 participants across 51 sites in 8 countries.
Detailed Summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesAustria, Belgium, Canada, Germany, Italy, Japan, Switzerland, United States
CollaboratorsBard Ltd
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionMay 2018
Study CompletionJun 2021
TodayJul 2026
First PostedJun 6, 2013
Enrollment StartJun 3, 2013
Primary CompletionMay 17, 2018
Study CompletionJun 22, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 13.1 years ago
Interventions
Lutonix DCBdevice
Uncoated PTA Catheterdevice