Trials / Completed
CompletedNCT01816412
LEVANT Japan Clinical Trial
A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 20 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.
Detailed description
The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.
Conditions
- Femoral Arterial Stenosis
- Stenosis of Popliteal Arteries
- Femoral Artery Occlusion
- Occlusion of Popliteal Arteries
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MD02-LDCB Paclitaxel coated balloon catheter | |
| PROCEDURE | Standard Uncoated Balloon Angioplasty Catheter |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2014-12-01
- Completion
- 2016-06-01
- First posted
- 2013-03-22
- Last updated
- 2016-09-28
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01816412. Inclusion in this directory is not an endorsement.