STRATEGY for Left Main Coronary Bifurcation Lesion II (STRATEGY-II)

Samsung Medical Center

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: One stent technique + Elective FKB; Device: Elective 2-stent; Procedure: Provisional approach; Device: One stent technique alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01798433

2012-12-039

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

One stent technique alone

Experimental group

Description:

One stent technique alone for non-true LM bifurcation

Treatment:

Device: One stent technique alone

One stent technique + Elective FKB

Experimental group

Description:

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

Treatment:

Device: One stent technique + Elective FKB

Provisional approach

Experimental group

Description:

Provisional approach for true LM bifurcation

Treatment:

Procedure: Provisional approach

Elective 2-stent

Experimental group

Description:

Elective 2-stent for true LM bifurcation

Treatment:

Device: Elective 2-stent