Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
Study NCT ID:
NCT04192760
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2019-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions
Sponsor:
University Heart Center Freiburg - Bad Krozingen
Organization:
Study Overview
Official Title:
Bifurcations Bad Krozingen (BBK) 3 - Trial Randomised Comparison of Culotte-stenting Versus DK-Crush--stenting for the Treatment of de Novo Non-left Main Coronary Bifurcation Lesions With Everolimus-eluting Stents
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
BBK-3
Brief Summary:
Randomised comparison of Culotte technique versus "Double Kissing" - Crush technique (DK-Crush) for the percutaneous treatment of de novo non-left main coronary bifurcation lesions with modern everolimus-eluting stents (DES) - German multicenter study
Detailed Description:
Aim of study This prospective randomized multicenter study will compare the long-term safety and efficacy of Culotte stenting versus "Double Kissing" - Crush (DK-Crush) stenting in the treatment of the de-novo non-left main coronary bifurcation lesions with new generation everolimus-eluting stents.
Study hypothesis In large coronary bifurcation lesions (main vessel \> 2.5mm, side branch \> 2.25mm) including significant ostial side branch disease, Culotte stenting compared with DKcrush stenting reduces maximal percent diameter stenosis at the bifurcation at 9-month follow-up by 25 %.
Study design Prospective, randomized, German multicenter study.
Methods Four-hundred patients, in whom a double-stenting technique is intended for the treatment of a non-left main de-novo coronary bifurcation lesion will be randomly assigned to Culotte stenting or to DK-crush stenting with an approved drug-eluting stent (SYNERGY-Stent). As a part of usual care, patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planned at 1 year if no angiographic follow-up is obtained.
Study hypothesis In large coronary bifurcation lesions (main vessel \> 2.5mm, side branch \> 2.25mm) including significant ostial side branch disease, Culotte stenting compared with DKcrush stenting reduces maximal percent diameter stenosis at the bifurcation at 9-month follow-up by 25 %.
Study design Prospective, randomized, German multicenter study.
Methods Four-hundred patients, in whom a double-stenting technique is intended for the treatment of a non-left main de-novo coronary bifurcation lesion will be randomly assigned to Culotte stenting or to DK-crush stenting with an approved drug-eluting stent (SYNERGY-Stent). As a part of usual care, patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planned at 1 year if no angiographic follow-up is obtained.
Study Oversight
Has Oversight DMC:
False
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?: