Coronary Artery DiseaseSTRATEGY-IINCT01798433
STRATEGY for Left Main Coronary Bifurcation Lesion II
A study testing One stent technique alone, One stent technique + Elective FKB and Provisional approach in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- One stent technique alone, One stent technique + Elective FKB and Provisional approach
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2013to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Coronary Artery Disease
- Being tested
- One stent technique alone, One stent technique + Elective FKB, Provisional approach, Elective 2-stent
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One stent technique aloneDevice
One stent technique alone with drug-eluting stent
One stent technique + Elective FKBDevice
One stent technique + Elective FKB with drug-eluting stents + balloon
Provisional approachProcedure or surgery
Provisional approach with drung-eluting stents
Elective 2-stentDevice
Elective 2-stent with drug-eluting stents
| Study group | Role | What they receive |
|---|---|---|
| One stent technique alone | Experimental | One stent technique alone for non-true LM bifurcation Receives: Device: One stent technique alone |
| One stent technique + Elective FKB | Experimental | One stent technique + Elective FKB for non-true LM bifurcation Receives: Device: One stent technique + Elective FKB |
| Provisional approach | Experimental | Provisional approach for true LM bifurcation Receives: Procedure: Provisional approach |
| Elective 2-stent | Experimental | Elective 2-stent for true LM bifurcation Receives: Device: Elective 2-stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
Measured: 12-month
Secondary outcomes (10)
Cardiac death
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Measured: 12-month
Angiographic in-segment restenosis rate
as measured by 9-month quantitative coronary analysis
Measured: 9 months
Target vessel revascularization (TVR)
TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.
Measured: 12-month
Stent thrombosis
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Measured: 12-month
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.
Measured: 12-month
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.
Measured: 12-month
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.
Measured: the first 48 hours after PCI
Procedure success rate
Measured: the first 48 hours after PCI
Procedure time
Measured: immediate after PCI
Amount of contrast dye
Measured: immediate after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study start18 Mar 2013
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
- Investigators
- Hyeon-Cheol Gwon, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798433
- Sponsor's protocol ID
- 2012-12-039
- Acronym
- STRATEGY-II
- Status last verified
- Dec 2018
- First submitted
- 11 Feb 2013
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01798433
- Acronym / sponsor ID
- STRATEGY-II / 2012-12-039
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One stent technique alone | Experimental | Device: One stent technique aloneOne stent technique alone for non-true LM bifurcation |
| One stent technique + Elective FKB | Experimental | Device: One stent technique + Elective FKBOne stent technique + Elective FKB for non-true LM bifurcation |
| Provisional approach | Experimental | Procedure: Provisional approachProvisional approach for true LM bifurcation |
| Elective 2-stent | Experimental | Device: Elective 2-stentElective 2-stent for true LM bifurcation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One stent technique aloneOne stent technique alone with drug-eluting stent | Device | One stent technique alone |
| One stent technique + Elective FKBOne stent technique + Elective FKB with drug-eluting stents + balloon | Device | One stent technique + Elective FKB |
| Provisional approachProvisional approach with drung-eluting stents | Procedure or surgery | Provisional approach |
| Elective 2-stentElective 2-stent with drug-eluting stents | Device | Elective 2-stent |
Primary outcome
Target lesion failure
Time frame: 12-month
defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
10 secondary outcomes
Cardiac death
Time frame: 12-month
Angiographic in-segment restenosis rate
Time frame: 9 months
Target vessel revascularization (TVR)
Time frame: 12-month
Stent thrombosis
Time frame: 12-month
Myocardial infarction (MI)
Time frame: 12-month
Target lesion revascularization (TLR)
Time frame: 12-month
Periprocedural CK-MB elevation
Time frame: the first 48 hours after PCI
Procedure success rate
Time frame: the first 48 hours after PCI
Procedure time
Time frame: immediate after PCI
Amount of contrast dye
Time frame: immediate after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon-Cheol Gwon, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One stent technique alone, One stent technique + Elective FKB and Provisional approach in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.