Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT05488665

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

Led by Yonsei University · Updated on 2024-10-23

512

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

B

Byeong-Keuk Kim, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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