Trials / Unknown
UnknownNCT02962232
A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW
Evaluation the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Below The Knee 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 to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.
Detailed description
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion inbelow the knee artery. This is a prospective, multi-center, randomized, control, opening, superiority designed clinical study. Plan to enroll 172 eligible subjects in 15 centers in China, all these subjects will be randomized 1:1 to the study group (LEGFLOW OTW group, n=86) and control group (AMPHIRION DEEP group, n=86), and accept the treatment of LEGFLOW OTW and AMPHIRION DEEP respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paclitaxel Releasing Peripheral Balloon Dilatation Catheter | treatment group |
| DEVICE | PTA catheter | control group |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2020-06-01
- Completion
- 2020-12-01
- First posted
- 2016-11-11
- Last updated
- 2018-11-29
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02962232. Inclusion in this directory is not an endorsement.