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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
One stent technique alone
One stent technique + Elective FKB
Provisional approach
Elective 2-stent
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angioplasty, Transluminal, Percutaneous Coronary

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

One stent technique alone

One stent technique + Elective FKB

Provisional approach

Elective 2-stent

Arm Description

One stent technique alone for non-true LM bifurcation

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

Provisional approach for true LM bifurcation

Elective 2-stent for true LM bifurcation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiac death
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Angiographic in-segment restenosis rate
as measured by 9-month quantitative coronary analysis
Target vessel revascularization (TVR)
TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.
Stent thrombosis
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
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.
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.
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.
Procedure success rate
Procedure time
Amount of contrast dye

Full Information

First Posted
February 11, 2013
Last Updated
December 29, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01798433
Brief Title
STRATEGY for Left Main Coronary Bifurcation Lesion II
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 18, 2013 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Angioplasty, Transluminal, Percutaneous Coronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One stent technique alone
Arm Type
Experimental
Arm Description
One stent technique alone for non-true LM bifurcation
Arm Title
One stent technique + Elective FKB
Arm Type
Experimental
Arm Description
One stent technique + Elective FKB for non-true LM bifurcation
Arm Title
Provisional approach
Arm Type
Experimental
Arm Description
Provisional approach for true LM bifurcation
Arm Title
Elective 2-stent
Arm Type
Experimental
Arm Description
Elective 2-stent for true LM bifurcation
Intervention Type
Device
Intervention Name(s)
One stent technique alone
Intervention Description
One stent technique alone with drug-eluting stent
Intervention Type
Device
Intervention Name(s)
One stent technique + Elective FKB
Intervention Description
One stent technique + Elective FKB with drug-eluting stents + balloon
Intervention Type
Procedure
Intervention Name(s)
Provisional approach
Intervention Description
Provisional approach with drung-eluting stents
Intervention Type
Device
Intervention Name(s)
Elective 2-stent
Intervention Description
Elective 2-stent with drug-eluting stents
Primary Outcome Measure Information:
Title
Target lesion failure
Description
defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Cardiac death
Description
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Time Frame
12-month
Title
Angiographic in-segment restenosis rate
Description
as measured by 9-month quantitative coronary analysis
Time Frame
9 months
Title
Target vessel revascularization (TVR)
Description
TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.
Time Frame
12-month
Title
Stent thrombosis
Description
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Time Frame
12-month
Title
Myocardial infarction (MI)
Description
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.
Time Frame
12-month
Title
Target lesion revascularization (TLR)
Description
TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
Time Frame
12-month
Title
Periprocedural CK-MB elevation
Description
Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.
Time Frame
the first 48 hours after PCI
Title
Procedure success rate
Time Frame
the first 48 hours after PCI
Title
Procedure time
Time Frame
immediate after PCI
Title
Amount of contrast dye
Time Frame
immediate after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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STRATEGY for Left Main Coronary Bifurcation Lesion II

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