Trials / Unknown
UnknownNCT04982367
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sirolimus-eluting balloon catheter | Sirolimus-eluting balloon catheter designed and produced by Acotec |
| DEVICE | Paclitaxel-eluting balloon catheter | Paclitaxel-eluting balloon catheter (trade name:DHALIA) |
Timeline
- Start date
- 2021-12-08
- Primary completion
- 2024-07-01
- Completion
- 2024-07-01
- First posted
- 2021-07-29
- Last updated
- 2023-10-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04982367. Inclusion in this directory is not an endorsement.