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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Drug-Coated Balloon
- Sponsor
- Harbin Medical University
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Fractional flow reserve (FFR)
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Yu Bo
The Head of cardiology department
The Second Affiliated Hospital of Harbin Medical University
Eligibility Criteria
Inclusion Criteria
- •Age≥18 Years and \<80 years;
- •ACS patients eligible for percutaneous coronary intervention;
- •Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
- •Vessel diameter from 2.25mm-4.0 mm ;
- •Lesion length ≤ 28 mm;
- •A single culprit lesion or 1 lesion in each of two vessels ;
- •Eligible for enrollment and provide written informed consent.
Exclusion Criteria
- •Clinical Exclusion Criteria：
- •Stable angina or asymptomatic myocardial ischemia;
- •Cardiogenic shock or requiring mechanical support for breathing and circulation;
- •Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
- •Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
- •A history of stroke within 6 months;
- •History of severe renal insufficiency;
- •Life expectancy \< 12 months;
- •Pregnant women;
- •Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
Outcomes
Primary Outcomes
Fractional flow reserve (FFR)
Time Frame: 9 months follow-up
Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
Secondary Outcomes
- Target lesion failure（TLF）(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Target vessel-related myocardial infarction(12 months, 24 months follow-up)
- Major bleeding(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Procedure success(1 month)
- Revascularization of target lesion revascularization (TLR)(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Restenosis rate of target lesion(9 months)
- Cardiac death(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- All-cause death and myocardial infarction(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Diameter stenosis(DS%)(9 months follow-up)
- Rehospitalized due to angina(2 years)
- Patient-oriented composite endpoint (PoCE)(1 month, 6 months, 9 months, 12 months ,24 months follow-up)
- Late lumen loss (LLL）(9 months follow-up)
- Definite and possible thrombotic events(2 years)
- Stroke(2 years)