Trials / Completed
CompletedNCT03267056
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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 |
|---|---|---|
| DEVICE | drug eluting balloon catheter (trade name: Orchid) | use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
Timeline
- Start date
- 2018-01-19
- Primary completion
- 2020-04-30
- Completion
- 2020-06-01
- First posted
- 2017-08-30
- Last updated
- 2020-08-19
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03267056. Inclusion in this directory is not an endorsement.