ACS, Acute Coronary Syndromes, Clinical Trial, Coronary Artery Disease, DCB, De Novo Stenosis, Drug-Coated Balloon
Conditions
Keywords
Drug-Coated Balloon, De-novo Lesions, Acute Coronary Syndromes, DCB-ACS, ACS, DCB, Clinical Trial, Coronary Artery Disease
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.
Interventions
DEVICEDrug-coated balloon
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 .
Sponsors
Daqing Oil Field Hospital
Sichuan Provincial People's Hospital
Tianjin People's Hospital
Peking University First Hospital
Beijing Friendship Hospital
The Third Medical Center, Chinese PLA General Hospital
Jining Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
The First Hospital of Jilin University
General Hospital of Taiyuan Iron & Steel Company
Tongji Hospital
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital of Zhengzhou University
Sir Run Run Shaw Hospital
Inner Mongolia People's Hospital
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥18 Years and \<80 years; 2. ACS patients eligible for percutaneous coronary intervention; 3. 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; 4. Vessel diameter from 2.25mm-4.0 mm ; 5. Lesion length ≤ 28 mm; 6. A single culprit lesion or 1 lesion in each of two vessels ; 7. Eligible for enrollment and provide written informed consent.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractional flow reserve (FFR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 1 month, 6 months, 9 months, 12 months, 24 months follow-up | — |
| Target vessel-related myocardial infarction | 12 months, 24 months follow-up | — |
| Revascularization of target lesion revascularization (TLR) | 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 | — |
| Major bleeding | 1 month, 6 months, 9 months, 12 months, 24 months follow-up | Defined as Bleeding Academic Research Consortium type 3 to 5 |
| Procedure success | 1 month | Including device success, lesion success and procedure success |
| Target lesion failure（TLF） | 1 month, 6 months, 9 months, 12 months, 24 months follow-up | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and revascularization of target lesions |
| Diameter stenosis(DS%) | 9 months follow-up | DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) \*100%. |
| Late lumen loss (LLL） | 9 months follow-up | The difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography. |
| Restenosis rate of target lesion | 9 months | Diameter stenosis %≥50% |
| Definite and possible thrombotic events | 2 years | — |
| Rehospitalized due to angina | 2 years | — |
| Stroke | 2 years | Diagnosed by a neurologist |
| Patient-oriented composite endpoint (PoCE) | 1 month, 6 months, 9 months, 12 months ,24 months follow-up | A composite of all-cause mortality, myocardial infarction, and any revascularization. |
Countries
China
Outcome results
None listed