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Recruiting NCT05488665

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

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Crush technique, Culotte technique.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device Crush technique
    Treatment for bifurcation with the Crush technique
  • Device Culotte technique
    Treatment for bifurcation with the culotte technique

Primary outcome measures

  • Target lesion failure [Time frame: 1 year]
Secondary outcome measures (6)
  • Cardiovascular death [Time frame: 1 year]
  • Target vessel myocardial infarction [Time frame: 1 year]
  • Clinically driven target-lesion revascularization [Time frame: 1 year]
  • All-cause of death [Time frame: 1 year]
  • Target-vessel or non-target vessel myocardial infarction [Time frame: 1 year]
  • Definite or probable stent thrombosis [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Age ≥19 years
  • De novo coronary lesions eligible for drug-eluting stent implantation
  • 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
  • Reference vessel diameter of side branch ≥2.5 mm by visual estimation

Exclusion criteria

  • Current or potential pregnancy
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Subjects with ST elevation myocardial infarction <24 h from the onset of chest pain
  • Cardiogenic Shock

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT05488665 · 1-2022-0033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗