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OpenTrials
Completed

NCT Number: NCT01798433

STRATEGY for Left Main Coronary Bifurcation Lesion II

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

One stent technique alone

Device

One stent technique alone with drug-eluting stent

One stent technique + Elective FKB

Device

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

Provisional approach

Procedure

Provisional approach with drung-eluting stents

Elective 2-stent

Device

Elective 2-stent with drug-eluting stents

Primary outcomes

  1. Target lesion failure

    Time frame: 12-month

    defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: STRATEGY-II

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2013
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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