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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
University Heart Center Freiburg • Bad Krozingen
Bad Krozingen, Suedring 15, Germany
RECRUITINGHerz-u. Diabeteszentrum
Bad Oeynhausen, Germany
RECRUITINGAngiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA)
For quantitative coronary angiography, changes between result at the completion of the index intervention and at 9 months follow-up will be analysed using a computer based system dedicated to bifurcation analysis, according to the standard operating procedure of the angiographic core laboratory. Quantitative angiographic measurements will be obtained of the three segments of the bifurcation lesion: the proximal and distal segment of the main branch and the side branch. We will perform measurements in the stented portion of the vessel (in-stent) and in the distal or proximal 5 mm margin (edge). In-segment analyses will comprise the in-stent and the edge area. In addition, the bifurcation angle from the analysis system will be estimated.
Time frame: 9 months post index percutaneous coronary intervention (PCI)
Incidence of target lesion revascularisation (TLR)
Any revascularisation (Re-PCI or CABG) at segments treated during index procedure
Time frame: 1 year
Incidence of major adverse cardiac events (MACE)
MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR
Time frame: 1 year
Incidence of binary restenosis at any segment of the bifurcation lesion
≥ 50% diameter stenosis in the main and side branch
Time frame: 9 months
Incidence of binary restenosis in the main and side branch
≥ 50% diameter stenosis in main and side branch
Time frame: 9 months
Incidence of stent thrombosis (ST)
Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria
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Herz-und Gefäßzentrum
Bad Segeberg, Germany
RECRUITINGSt. Johannes-Hospital
Dortmund, Germany
RECRUITINGHerzzentrum Dresden an der Technischen Universität
Dresden, Germany
RECRUITINGElisabeth Krankenhaus
Essen, Germany
RECRUITINGUniversitätsklinikum Gießen
Giessen, Germany
RECRUITINGUniversitätsklinikum Leipzig
Leipzig, Germany
RECRUITINGUniversitätsklinik Mannheim
Mannheim, Germany
RECRUITINGDeutsches Herzzentrum
München, Germany
RECRUITING...and 3 more locations
Time frame: 1 year