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

Not Applicable

• Conditions: Coronary Stenosis; Stent Stenosis

• Registration Number: NCT04192760
• Lead Sponsor: University Heart Center Freiburg - Bad Krozingen

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 Timeline

• Study First Submitted: 2019-11-27
• Study Start: 2019-12-01
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05
• Primary Completion: 2023-03-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Clinical indication, evidenced by angina / angina-equivalent symptoms or documented ischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR or iwFR) or patients with acute coronary syndromes (NSTE-ACS).
2. Clinical indication to perform double stenting only with Synergy™ stents for a clinically significant bifurcation stenosis as judged by the operator.
3. De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to the Medina classification - of a native coronary artery with the following reference vessel diameters: main branch > 2,5 mm; side branch > 2,25 mm. The difference between vessel diameter of the main and side branch is ≤ 1 mm.
4. The target lesion has not been previously treated with any interventional procedure.
5. The target vessel (main branch and side branch) must appear feasible for stent implantation.
6. Patient has no other coronary intervention planned within 30 days of the procedure.
7. Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
8. Patient is willing to comply with all required post-procedure follow-up.

Exclusion Criteria

1. Patient had an acute ST-elevation myocardial infarction within 72 h preceding the index procedure or target vessel contains intraluminal thrombus.
2. Use of any other coronary stent than Synergy™ and Synergy Megatron™ except for baiI-out situations.
3. Patient with a known hypersensitivity or contraindication to the needed antithrombotic therapy, stent type or contrast media that cannot be adequately pre-medicated.
4. Non successful treatment of other lesion during the same procedure.
5. Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease.
6. Patient has a co-morbidity (i.e. cancer) that may cause the patient to be noncompliant with the protocol, or is associated with limited life-expectancy (Iess than 1 year).
7. Patient is participating in any other clinical study with an investigational product.
8. Patient is known to be pregnant or lactating at time of inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Angiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA)	9 months post index percutaneous coronary intervention (PCI)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of stent thrombosis (ST)	1 year	Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria
Incidence of major adverse cardiac events (MACE)	1 year	MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR
Incidence of target lesion revascularisation (TLR)	1 year	Any revascularisation (Re-PCI or CABG) at segments treated during index procedure
Incidence of binary restenosis at any segment of the bifurcation lesion	9 months	≥ 50% diameter stenosis in the main and side branch
Incidence of binary restenosis in the main and side branch	9 months	≥ 50% diameter stenosis in main and side branch

Trial Locations

Locations (13)

University Heart Center Freiburg • Bad Krozingen; 🇩🇪 Bad Krozingen, Suedring 15, Germany

Herz-u. Diabeteszentrum; 🇩🇪 Bad Oeynhausen, Germany

Herz-und Gefäßzentrum; 🇩🇪 Bad Segeberg, Germany

St. Johannes-Hospital; 🇩🇪 Dortmund, Germany

Herzzentrum Dresden an der Technischen Universität; 🇩🇪 Dresden, Germany

Elisabeth Krankenhaus; 🇩🇪 Essen, Germany

Universitätsklinikum Gießen; 🇩🇪 Gießen, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinik Mannheim; 🇩🇪 Mannheim, Germany

Deutsches Herzzentrum; 🇩🇪 München, Germany

Scroll for more (3 remaining)