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Clinical Trials in South Korea / NCT05488665
Recruiting Not applicable

The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique

NCT05488665 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2022-11-10
Last updated
2024-10-23

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Crush techniqueCulotte technique

Crush technique: Treatment for bifurcation with the Crush technique

Culotte technique: Treatment for bifurcation with the culotte technique

Study summary

In this COMPLETE randomized trial, using the contemporary second-generation drug-eluting stent, we aimed to test whether the crush technique is superior to the culotte technique for the treatment of bifurcation lesions in terms of 1-year target-lesion failure.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. Age ≥19 years 2. De novo coronary lesions eligible for drug-eluting stent implantation 3. Medina 1,1,1 or 1,0,1 or 0,1,1 de novo bifurcation lesions (LM or non-LM) and those of main vessel or side branch can be covered by 2 stents 4. Reference vessel diameter of side branch ≥2.5 mm by visual estimation Exclusion criteria 1. Current or potential pregnancy 2. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 3. Subjects with ST elevation myocardial infarction \<24 h from the onset of chest pain 4. Cardiogenic Shock

Primary outcome measure(s)

  • Target lesion failure — 1 year
    The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05488665 on ClinicalTrials.gov ↗ ← All trials in South Korea