Trials / Unknown
UnknownNCT06345209
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels
A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter for the Treatment of De Novo Coronary Artery Small Vessel Lesions.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- Sponsor
- BrosMed Medical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sirolimus-coated Coronary Balloon Dilatation Catheter | During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure |
| DEVICE | Drug-coated Coronary Balloon Dilatation Catheter | During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Drug-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure |
Timeline
- Start date
- 2024-05-01
- Primary completion
- 2024-12-01
- Completion
- 2025-12-01
- First posted
- 2024-04-03
- Last updated
- 2024-04-03
Source: ClinicalTrials.gov record NCT06345209. Inclusion in this directory is not an endorsement.