Trials / Completed
CompletedNCT01850056
AcoArt Ⅰ / SFA China
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | drug eluting balloon catheter (trade name: Orchid) | |
| DEVICE | common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2016-08-01
- Completion
- 2016-09-01
- First posted
- 2013-05-09
- Last updated
- 2018-07-12
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01850056. Inclusion in this directory is not an endorsement.