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

Coronary Artery Disease Clinical Trial

Official title:
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

Clinical Trial 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) .

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04937803
Study type Interventional
Source Harbin Medical University
Contact
Status Active, not recruiting
Phase N/A
Start date April 19, 2021
Completion date March 31, 2024
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