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

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.

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 Exclusion Criteria：

1. Stable angina or asymptomatic myocardial ischemia;
2. Cardiogenic shock or requiring mechanical support for breathing and circulation;
3. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
4. Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
5. A history of stroke within 6 months;
6. History of severe renal insufficiency;
7. Life expectancy < 12 months;
8. Pregnant women;
9. Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
10. Patients not suitable for enrollment considered by researcher;
11. Currently participating in another trial before reaching the primary endpoint;
12. 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.