Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Drug-Coated Balloon, De Novo Stenosis, Acute Coronary Syndromes, ACS, DCB, Clinical Trial, Coronary Artery Disease

Intervention / Treatment
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* Device: Drug-coated balloon
* Device: Zotarolimus-Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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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; Patients not suitable for enrollment considered by researcher; Currently participating in another trial before reaching the primary endpoint; Inability to provide informed consent. Image Exclusion Criteria 1. Chronic total occlusion (CTO); 2. Left main lesion; 3. Bifurcation lesions treated with double stents; 4. Moderate to severe distortion, angulation or severe calcification lesions; 5. Coronary artery graft stenosis; 6. In-stent restenosis; 7. To be re-hospitalized for the other scheduled PCI treatment; 8. Myocardial bridge at the target lesion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-coated balloon group<br>Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions. | Device: Drug-coated balloon<br>* Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow.<br>|
| Active Comparator: Stent group<br>Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment . | Device: Zotarolimus-Eluting Coronary Stent<br>* Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure（TLF） | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and revascularization of target lesions | 1 month, 6 months, 9 months, 12 months, 24 months follow-up | 
| 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 | Defined as Bleeding Academic Research Consortium type 3 to 5 | 1 month, 6 months, 9 months, 12 months, 24 months follow-up | 
| Procedure success | Including device success, lesion success and procedure success | 1 month | 
| Patient-oriented composite endpoint (PoCE) | A composite of all-cause mortality, myocardial infarction, and any revascularization. | 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%. | 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. | 9 months follow-up | 
| Restenosis rate of target lesion | Diameter stenosis %≥50% | 9 months | 
| Definite and possible thrombotic events |  | 2 years | 
| Rehospitalized due to angina |  | 2 years | 
| Stroke | Diagnosed by a neurologist | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Coated Balloon, De-novo Lesions, Acute Coronary Syndromes, DCB-ACS, ACS, DCB, Clinical Trial, Coronary Artery Disease