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

Harbin Medical University

Status: Completed

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

Treatments: Device: Drug-coated balloon; Device: Zotarolimus-Eluting Coronary Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT04937803

LPCTP-2020-001

Details and patient eligibility

About

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) .

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

13. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Drug-coated balloon group

Experimental group

Description:

Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions.

Treatment:

Device: Drug-coated balloon

Stent group

Active Comparator group

Description:

Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment .

Treatment:

Device: Zotarolimus-Eluting Coronary Stent