Trials / Completed
CompletedNCT04631055
AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intracranial Drug-coated Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic 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 the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.
Detailed description
This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is angiographic restenosis at 6 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | drug coated balloon | paclitaxel coated balloon catheter for intracranial PTA treatment |
| DEVICE | stent system | The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA. |
Timeline
- Start date
- 2021-06-04
- Primary completion
- 2023-04-10
- Completion
- 2023-04-13
- First posted
- 2020-11-17
- Last updated
- 2024-08-23
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04631055. Inclusion in this directory is not an endorsement.