Trials / Completed
CompletedNCT04937803
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS): A Prospective, Multi-Center, Randomized-Controlled Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Harbin Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary syndromes (ACS) .
Detailed description
Patients with ACS and indications for percutaneous coronary intervention were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a Zotarolimus-Eluting Coronary Stent(ZES) . Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, 12 months, and 24 months after discharge, and coronary angiography and FFR measurements will be carried out at 9 months.The primary objective is to show non-inferiority of DCB versus drug-eluting stent(DES) regarding the functional assessment of target lesion by FFR at 9 months.
Conditions
- Drug-Coated Balloon
- De Novo Stenosis
- Acute Coronary Syndromes
- ACS
- DCB
- Clinical Trial
- Coronary Artery Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug-coated balloon | Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow. |
| DEVICE | Zotarolimus-Eluting Coronary Stent | Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions . |
Timeline
- Start date
- 2021-04-19
- Primary completion
- 2023-02-18
- Completion
- 2023-11-17
- First posted
- 2021-06-24
- Last updated
- 2024-07-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04937803. Inclusion in this directory is not an endorsement.