Trials / Unknown
UnknownNCT04626687
ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
Detailed description
This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | test DCB | use paclitaxel coated coronary balloon catheters to treat SVD |
| DEVICE | RESTORE DCB | use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD |
Timeline
- Start date
- 2021-04-06
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2020-11-12
- Last updated
- 2024-01-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04626687. Inclusion in this directory is not an endorsement.