Trials / Completed
CompletedNCT02720003
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.
Detailed description
The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .
Conditions
- Femoral Artery Stenosis
- Femoral Artery Occlusion
- Stenosis of Popliteal Arteries
- Occlusion of Popliteal Arteries
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LTX DCB | Treatment with a drug-coated balloon |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-10-01
- Completion
- 2020-08-01
- First posted
- 2016-03-25
- Last updated
- 2021-01-20
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02720003. Inclusion in this directory is not an endorsement.