Trials / Recruiting
RecruitingNCT04627870
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis
A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Detailed description
This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | drug (paclitaxel) coated balloon | use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis |
| DEVICE | PTA balloon | use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis |
Timeline
- Start date
- 2021-05-26
- Primary completion
- 2024-12-30
- Completion
- 2025-12-30
- First posted
- 2020-11-13
- Last updated
- 2024-08-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04627870. Inclusion in this directory is not an endorsement.