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

Yonsei University

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Crush technique; Device: Culotte technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05488665

1-2022-0033

Details and patient eligibility

About

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.

Enrollment: 512 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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512 participants in 2 patient groups

Crush technique group

Experimental group

Description:

Two stenting with the Crush technique

Treatment:

Device: Crush technique

Culotte technique group

Active Comparator group

Description:

Two stenting with the Culotte technique

Treatment:

Device: Culotte technique