Comparison of Double-kissing Crush and Double-kissing Culotte Stenting

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: double kissing crush stenting; Procedure: double kissing culotte stenting

• Registration Number: NCT04789161
• Lead Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Brief Summary

True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy. Although the provisional stenting is still effective in suitable lesions, double stent techniques can be required in selected patients. In previous studies, double kissing crush (DK-crush) stenting was revealed as superior to provisional stenting in TBL of left main coronary artery. Additionally, in recent studies, double kissing approach facilitates and highlights double kissing culotte (DK-culotte) stenting with lower stent malapposition compared to DK-crush stenting. However, to the best of our knowledge, there is no study about comparing DK-crush and DK-culotte stenting in TBLs. Our aim in this study is to compare DK-crush and DK-culotte stenting in patients with TBL.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-07
• Study First Posted: 2021-03-09
• Primary Completion: 2024-04-04
• Study Completion: 2024-05-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
• The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm

Exclusion Criteria

• Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
• Patients with a history of coronary artery bypass grafting surgery
• Patients with a chronic total occlusion in the bifurcation area
• Lesions with severe calcification that needs additional intervention such as atherectomy
• Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
• Patients with hematological disorders, malignancy, end stage renal (GFR<30 ml/min) and hepatic failure
• Patients with active bleeding
• Pregnant women
• Patients with life-expectancy < 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
double kissing crush stenting	double kissing crush stenting	patients with true bifurcation lesion undergoing double kissing crush stenting
double kissing culotte stenting	double kissing culotte stenting	patients with true bifurcation lesion undergoing double kissing culotte stenting

Primary Outcome Measures

Name	Time	Method
MACE (major adverse cardiovascular events)	12 months	target vessel revascularization, myocardial infarction and cardiac death

Secondary Outcome Measures

Name	Time	Method
target lesion failure	24, 36 months	myocardial infarction, cardiac death
MACCEs (major adverse cerebral and cardiovascular events)	12, 24, 36 months	all cause death, myocardial infarction, target lesion revascularization, target lesion revascularization, in-stent thrombosis and/or restenosis, stroke

Trial Locations

Locations (1)

Istanbul Mehmet Akif Ersoy Training and Research Hospital; 🇹🇷 Istanbul, Turkey