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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2028-09-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crush technique group

Two stenting with the Crush technique

Group Type EXPERIMENTAL

Crush technique

Intervention Type DEVICE

Treatment for bifurcation with the Crush technique

Culotte technique group

Two stenting with the Culotte technique

Group Type ACTIVE_COMPARATOR

Culotte technique

Intervention Type DEVICE

Treatment for bifurcation with the culotte technique

Interventions

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Crush technique

Treatment for bifurcation with the Crush technique

Intervention Type DEVICE

Culotte technique

Treatment for bifurcation with the culotte technique

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No