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Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions — BBK-3  

Coronary Stenosis Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04192760
Study type Interventional
Source University Heart Center Freiburg - Bad Krozingen
Contact Miroslaw Ferenc, MD
Phone 0049 7633 4020
Email miroslaw.ferenc@uniklinik-freiburg.de
Status Recruiting
Phase N/A
Start date December 1, 2019
Completion date December 31, 2023
View Details
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