Trials / Completed
CompletedNCT02137577
AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
Detailed description
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia. DEBs are designed to promote arterial patency by reducing neointimal proliferation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | DEB catheter | DEB catheter (trade name: Litos/Tulip) |
| PROCEDURE | common PTA balloon catheter | common PTA balloon catheter |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2018-11-01
- Completion
- 2020-12-17
- First posted
- 2014-05-14
- Last updated
- 2021-06-18
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02137577. Inclusion in this directory is not an endorsement.