STRATEGY for Left Main Coronary Bifurcation Lesion II

Coronary Artery Disease Clinical Trial

— STRATEGY-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798433
• Other study ID #: 2012-12-039
• Status: Completed
• Phase: N/A
• Start date: March 18, 2013
• Est. completion date: July 31, 2018

Study information

• Verified date: December 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• One stent technique alone
One stent technique alone with drug-eluting stent
• One stent technique + Elective FKB
One stent technique + Elective FKB with drug-eluting stents + balloon

Procedure:
• Provisional approach
Provisional approach with drung-eluting stents

Device:
• Elective 2-stent
Elective 2-stent with drug-eluting stents

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization	12-month
Secondary	Cardiac death	All deaths were considered cardiac unless a definite non-cardiac cause could be established.	12-month
Secondary	Angiographic in-segment restenosis rate	as measured by 9-month quantitative coronary analysis	9 months
Secondary	Target vessel revascularization (TVR)	TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.	12-month
Secondary	Stent thrombosis	Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.	12-month
Secondary	Myocardial infarction (MI)	MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure.	12-month
Secondary	Target lesion revascularization (TLR)	TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.	12-month
Secondary	Periprocedural CK-MB elevation	Periprocedural enzyme elevation was defined as a rise in CK-MB =3 times the upper normal limit after the index procedure.	the first 48 hours after PCI
Secondary	Procedure success rate		the first 48 hours after PCI
Secondary	Procedure time		immediate after PCI
Secondary	Amount of contrast dye		immediate after PCI