Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618248
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon SuperFlow versus Paclitaxel-coated balloon Bingo in the treatment of coronary bifurcation lesions
Detailed Description:
This is a prospective multicenter randomized controlled non-inferiority trial conducted across 13-20 sites The study aims to enroll 280 patients with true coronary bifurcation lesions in native coronary arteries
Eligible patients will be randomized in a 11 ratio to receive either the Sirolimus-coated spiral balloon SuperFlow or the Paclitaxel-coated balloon Bingo following a site-specific blocked randomization schedule
All participants will be screened based on the trials predefined inclusion and exclusion criteria Data and imaging will be collected during the index procedure and at the predefined 9-month clinical follow-up visit
Eligible patients will be randomized in a 11 ratio to receive either the Sirolimus-coated spiral balloon SuperFlow or the Paclitaxel-coated balloon Bingo following a site-specific blocked randomization schedule
All participants will be screened based on the trials predefined inclusion and exclusion criteria Data and imaging will be collected during the index procedure and at the predefined 9-month clinical follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None