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

• ClinicalTrials.gov Identifier: NCT01798433
• Recruitment Status: Completed
• First Posted: February 25, 2013
• Last Update Posted: January 2, 2019
• Sponsor: Samsung Medical Center
• Information provided by (Responsible Party): Hyeon-Cheol Gwon, Samsung Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: One stent technique alone; Device: One stent technique + Elective FKB; Procedure: Provisional approach; Device: Elective 2-stent	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 18, 2013
• Actual Primary Completion Date: July 31, 2018
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: One stent technique alone; One stent technique alone for non-true LM bifurcation	Device: One stent technique alone; One stent technique alone with drug-eluting stent
Experimental: One stent technique + Elective FKB; One stent technique + Elective FKB for non-true LM bifurcation	Device: One stent technique + Elective FKB; One stent technique + Elective FKB with drug-eluting stents + balloon
Experimental: Provisional approach; Provisional approach for true LM bifurcation	Procedure: Provisional approach; Provisional approach with drung-eluting stents
Experimental: Elective 2-stent; Elective 2-stent for true LM bifurcation	Device: Elective 2-stent; Elective 2-stent with drug-eluting stents

Outcome Measures

Primary Outcome Measures :

1. Target lesion failure [ Time Frame: 12-month ]
   defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization

Secondary Outcome Measures :

1. Cardiac death [ Time Frame: 12-month ]
   All deaths were considered cardiac unless a definite non-cardiac cause could be established.
2. Angiographic in-segment restenosis rate [ Time Frame: 9 months ]
   as measured by 9-month quantitative coronary analysis
3. Target vessel revascularization (TVR) [ Time Frame: 12-month ]
   TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.
4. Stent thrombosis [ Time Frame: 12-month ]
   Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
5. Myocardial infarction (MI) [ Time Frame: 12-month ]
   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.
6. Target lesion revascularization (TLR) [ Time Frame: 12-month ]
   TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
7. Periprocedural CK-MB elevation [ Time Frame: the first 48 hours after PCI ]
   Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.
8. Procedure success rate [ Time Frame: the first 48 hours after PCI ]
9. Procedure time [ Time Frame: immediate after PCI ]
10. Amount of contrast dye [ Time Frame: immediate after PCI ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

• Principal Investigator: Hyeon-Cheol Gwon, MD,PhD; Samsung Medical Center

More Information

• Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01798433
• Other Study ID Numbers: 2012-12-039
• First Posted: February 25, 2013
• Last Update Posted: January 2, 2019
• Last Verified: December 2018

Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:

Angioplasty; Transluminal; Percutaneous Coronary

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases