Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846893
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2023-04-11
Brief Title:
Drug-Coated Balloon vs Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Sponsor:
B Braun Medical Industries Sdn Bhd
Organization:
B Braun Medical Industries Sdn Bhd
Study Overview
Official Title:
Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-05
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:
REVERSE
Brief Summary:
Prospective randomised open-label international multicenter trial to evaluate the safety and efficacy of drug-coated balloon DCB treatment compared to drug-eluting stenting DES in patients with large coronary artery disease
Detailed Description:
Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes there is limited randomised controlled trial RCT data on the safety and efficacy of DCB in large coronary artery disease
Therefore the study aims to demonstrate the non-inferiority of the drug-coated balloon DCB treatment against current-generation drug-eluting stenting DES in patients with de novo lesions in large coronary artery disease reference vessel diameter 30 mm by visual estimation
The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES
Therefore the study aims to demonstrate the non-inferiority of the drug-coated balloon DCB treatment against current-generation drug-eluting stenting DES in patients with de novo lesions in large coronary artery disease reference vessel diameter 30 mm by visual estimation
The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES
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