Trials / Completed
CompletedNCT03910166
AcoArt VI / Vertebral Artery Ostium Stenosis in China
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (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 not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
Detailed description
Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis . DEBs are designed to promote arterial patency by reducing neointimal proliferation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | drug-coated balloon catheter（Orchid, Acotec） | After predilation, using drug-coated balloon catheter to cover the whole treated segment |
| PROCEDURE | Intracranial artery stent system（APOLLO） | stent assisted angioplasty |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2023-07-07
- Completion
- 2023-10-01
- First posted
- 2019-04-10
- Last updated
- 2024-08-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03910166. Inclusion in this directory is not an endorsement.