Viewing Study NCT04937803



Ignite Creation Date: 2024-05-06 @ 4:17 PM
Last Modification Date: 2024-10-26 @ 2:07 PM
Study NCT ID: NCT04937803
Status: COMPLETED
Last Update Posted: 2023-08-22
First Post: 2021-06-10

Brief Title: Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes DCB-ACS
Sponsor: Harbin Medical University
Organization: Harbin Medical University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DCB-ACS
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 balloonDCB in de novo lesions for acute coronary syndromes ACS
Detailed Description: Patients with ACS and indications for percutaneous coronary intervention were randomly assigned 11 to receive angioplasty with DCB or implantation of a Zotarolimus-Eluting Coronary StentZES 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 monthsThe primary objective is to show non-inferiority of DCB versus drug-eluting stentDES regarding the functional assessment of target lesion by FFR at 9 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None