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

Not Applicable

Completed

• Conditions: Drug-Coated Balloon; Clinical Trial; Coronary Artery Disease; Acute Coronary Syndromes; DCB; De Novo Stenosis; ACS
• Interventions: Device: Drug-coated balloon; Device: Zotarolimus-Eluting Coronary Stent

• Registration Number: NCT04937803
• Lead Sponsor: Harbin Medical University

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.

Study Timeline

• Study Start: 2021-04-19
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-24
• Primary Completion: 2023-02-18
• Study Completion: 2023-11-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-coated balloon group	Drug-coated balloon	Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions.
Stent group	Zotarolimus-Eluting Coronary Stent	Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stroke	2 years	Diagnosed by a neurologist
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
Target vessel-related myocardial infarction	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
Revascularization of target lesion revascularization (TLR)	1 month, 6 months, 9 months, 12 months, 24 months follow-up
Restenosis rate of target lesion	9 months	Diameter stenosis %≥50%
Cardiac death	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
Diameter stenosis(DS%)	9 months follow-up	DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) \*100%.
Rehospitalized due to angina	2 years
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.
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.
Definite and possible thrombotic events	2 years

Trial Locations

Locations (1)

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China