NCT01798433

Brief Summary

In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion. In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

March 18, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

5.4 years

First QC Date

February 11, 2013

Last Update Submit

December 29, 2018

Conditions

Coronary Artery Disease

Keywords

AngioplastyTransluminalPercutaneous Coronary

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization

    12-month

Secondary Outcomes (10)

  • Cardiac death

    12-month

  • Angiographic in-segment restenosis rate

    9 months

  • Target vessel revascularization (TVR)

    12-month

  • Stent thrombosis

    12-month

  • Myocardial infarction (MI)

    12-month

  • +5 more secondary outcomes

Study Arms (4)

One stent technique alone

EXPERIMENTAL

One stent technique alone for non-true LM bifurcation

Device: One stent technique alone

One stent technique + Elective FKB

EXPERIMENTAL

One stent technique + Elective FKB for non-true LM bifurcation

Device: One stent technique + Elective FKB

Provisional approach

EXPERIMENTAL

Provisional approach for true LM bifurcation

Procedure: Provisional approach

Elective 2-stent

EXPERIMENTAL

Elective 2-stent for true LM bifurcation

Device: Elective 2-stent

Interventions

One stent technique aloneDEVICE

One stent technique alone with drug-eluting stent

One stent technique alone
One stent technique + Elective FKBDEVICE

One stent technique + Elective FKB with drug-eluting stents + balloon

One stent technique + Elective FKB
Provisional approachPROCEDURE

Provisional approach with drung-eluting stents

Provisional approach
Elective 2-stentDEVICE

Elective 2-stent with drug-eluting stents

Elective 2-stent

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥20 years
  • Left main bifurcation lesion on coronary angiography
  • Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test
  • Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation

You may not qualify if:

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus
  • Patients who have received DES implantation in the target lesion prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hyeon-Cheol Gwon, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 25, 2013

Study Start

March 18, 2013

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

January 2, 2019

Record last verified: 2018-12

Locations

KR(1)