Trials / Unknown
UnknownNCT02965677
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW
Evaluation of the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Femoral-popliteal Arteries：A Prospective, Multicenter, Randomized, Controlled Clinical Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.
Detailed description
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery. This is a prospective, multicenter, prior desiged, randomize and controlled study, planned to enrol 172 subjects. all these subjects will be allocated 1:1 to the LEGFLOW OTW group n=86 and Admiral Xtreme group n=86. and accept the treatment of LEGFLOW and Admiral Xtreme balloon. and followed up at day 0-30, month 6, 12 by DUS and clinical examination. all the endpoint data will be assessed by DUS core-lab, CEC, then be statisticed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paclitaxel Releasing Peripheral Balloon Dilatation Catheter | in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter |
| DEVICE | Peripheral Balloon Dilatation Catheter | in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2020-12-01
- Completion
- 2021-06-01
- First posted
- 2016-11-17
- Last updated
- 2018-11-29
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02965677. Inclusion in this directory is not an endorsement.