Coronary Artery DiseaseCOMPLETENCT05488665
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
A study testing Crush technique and Culotte technique in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Crush technique and Culotte technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2022to 27 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Byeong-Keuk Kim, MD, PhD, 82-02-2228-8465, KIMBK@yuhs.ac
About this study
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
- Coronary Artery Disease
- Being tested
- Crush technique, Culotte technique
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crush techniqueDevice
Treatment for bifurcation with the Crush technique
Culotte techniqueDevice
Treatment for bifurcation with the culotte technique
| Study group | Role | What they receive |
|---|---|---|
| Crush technique group | Experimental | Two stenting with the Crush technique Receives: Device: Crush technique |
| Culotte technique group | Active comparator | Two stenting with the Culotte technique Receives: Device: Culotte technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization
Measured: 1 year
Secondary outcomes (6)
Cardiovascular death
Death resulting from cardiovascular causes.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
All-cause of death
Measured: 1 year
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.
Measured: 1 year
Definite or probable stent thrombosis
Stent thrombosis is defined according to the Academic Research Consortium definition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start10 Nov 2022
- Primary completion27 Sep 2027 (estimated)
- Study completion27 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeong-Keuk Kim, MD, PhD, Principal investigator, Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488665
- Sponsor's protocol ID
- 1-2022-0033
- Acronym
- COMPLETE
- Status last verified
- Oct 2024
- First submitted
- 3 Aug 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
- ClinicalTrials.gov ID
- NCT05488665
- Acronym / sponsor ID
- COMPLETE / 1-2022-0033
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 27 Sep 2027 (estimated)
- Study completion
- 27 Sep 2028 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crush technique group | Experimental | Device: Crush techniqueTwo stenting with the Crush technique |
| Culotte technique group | Active comparator | Device: Culotte techniqueTwo stenting with the Culotte technique |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crush techniqueTreatment for bifurcation with the Crush technique | Device | Crush technique group |
| Culotte techniqueTreatment for bifurcation with the culotte technique | Device | Culotte technique group |
Primary outcome
Target lesion failure
Time frame: 1 year
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Byeong-Keuk Kim, MD, PhD principal investigator
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crush technique and Culotte technique in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byeong-Keuk Kim, MD, PhD (82-02-2228-8465, KIMBK@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.