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RecruitingNCT05488665COMPLETEUpdated Oct 23, 2024

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

An interventional study of Crush technique and Culotte technique in Coronary Artery Disease, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
512
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 512 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
512 participants (estimated)

Study arms

  • Experimental
    Crush technique group

    Two stenting with the Crush technique

    Device: Crush technique

  • Active comparator
    Culotte technique group

    Two stenting with the Culotte technique

    Device: Culotte technique

Interventions

  • DeviceCrush technique

    Treatment for bifurcation with the Crush technique

  • DeviceCulotte technique

    Treatment for bifurcation with the culotte technique

06

What researchers measure

Primary outcomes

  1. Target lesion failure

    The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization

    Time frame: 1 year

Secondary outcomes

  1. Cardiovascular death

    Death resulting from cardiovascular causes.

    Time frame: 1 year

  2. Target vessel myocardial infarction

    The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.

    Time frame: 1 year

  3. Clinically driven target-lesion revascularization

    a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

    Time frame: 1 year

  4. All-cause of death

    Time frame: 1 year

  5. Target-vessel or non-target vessel myocardial infarction

    The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.

    Time frame: 1 year

  6. Definite or probable stent thrombosis

    Stent thrombosis is defined according to the Academic Research Consortium definition

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Yonsei University Health System, Severance Hospital
    Seoul, Korea, Republic of
    • Byeong-Keuk Kim, MD, PhD · Contact · KIMBK@yuhs.ac · 82-02-2228-8465
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05488665
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Aug 4, 2022
Start date
Nov 10, 2022
Primary completion
Sep 27, 2027 (estimated)
Completion
Sep 27, 2028 (estimated)
Last update
Oct 23, 2024

Study contacts

Byeong-Keuk Kim, MD, PhD
Contact
KIMBK@yuhs.ac
82-02-2228-8465
Byeong-Keuk Kim, MD, PhD
principal investigator · Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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