Completed

STRATEGY-IIA Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion

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What is being tested

One stent technique alone

+ One stent technique + Elective FKB

+ Provisional approach

DeviceProcedure
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 20 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorSamsung Medical Center
Last updated: January 2, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: March 18, 2013

Actual date on which the first participant was enrolled.

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.

NCT01798433
Principal SponsorSamsung Medical Center
Last updated: January 2, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery Disease

Criteria

4 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
Patients who have received DES implantation in the target lesion prior to enrollment
The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
One stent technique alone for non-true LM bifurcation

Group II

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

Group III

Experimental
Provisional approach for true LM bifurcation

Group IV

Experimental
Elective 2-stent for true LM bifurcation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Samsung Medical Center

Seoul, South KoreaOpen Samsung Medical Center in Google Maps
CompletedOne Study Center