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) .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow.
Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions .
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Fractional flow reserve (FFR)
Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
Time frame: 9 months follow-up
Target lesion failure(TLF)
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and revascularization of target lesions
Time frame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
Cardiac death
Time frame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
Target vessel-related myocardial infarction
Time frame: 12 months, 24 months follow-up
Revascularization of target lesion revascularization (TLR)
Time frame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
All-cause death and myocardial infarction
Time frame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
Major bleeding
Defined as Bleeding Academic Research Consortium type 3 to 5
Time frame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
Procedure success
Including device success, lesion success and procedure success
Time frame: 1 month
Patient-oriented composite endpoint (PoCE)
A composite of all-cause mortality, myocardial infarction, and any revascularization.
Time frame: 1 month, 6 months, 9 months, 12 months ,24 months follow-up
Diameter stenosis(DS%)
DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) \*100%.
Time frame: 9 months follow-up
Late lumen loss (LLL)
The difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography.
Time frame: 9 months follow-up
Restenosis rate of target lesion
Diameter stenosis %≥50%
Time frame: 9 months
Definite and possible thrombotic events
Time frame: 2 years
Rehospitalized due to angina
Time frame: 2 years
Stroke
Diagnosed by a neurologist
Time frame: 2 years
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