STRATEGY for Left Main Coronary Bifurcation Lesion II

NCT ID: NCT01798433

Last Updated: 2019-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-18

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One stent technique alone

One stent technique alone for non-true LM bifurcation

Group Type EXPERIMENTAL

One stent technique alone

Intervention Type DEVICE

One stent technique alone with drug-eluting stent

One stent technique + Elective FKB

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

Group Type EXPERIMENTAL

One stent technique + Elective FKB

Intervention Type DEVICE

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

Provisional approach

Provisional approach for true LM bifurcation

Group Type EXPERIMENTAL

Provisional approach

Intervention Type PROCEDURE

Provisional approach with drung-eluting stents

Elective 2-stent

Elective 2-stent for true LM bifurcation

Group Type EXPERIMENTAL

Elective 2-stent

Intervention Type DEVICE

Elective 2-stent with drug-eluting stents

Interventions

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One stent technique alone

One stent technique alone with drug-eluting stent

Intervention Type DEVICE

One stent technique + Elective FKB

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

Intervention Type DEVICE

Provisional approach

Provisional approach with drung-eluting stents

Intervention Type PROCEDURE

Elective 2-stent

Elective 2-stent with drug-eluting stents

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥20 years
2. Left main bifurcation lesion on coronary angiography
3. 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
4. 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

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyeon-Cheol Gwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyeon-Cheol Gwon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-12-039

Identifier Type: -

Identifier Source: org_study_id

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