Coronary Artery DiseaseNCT00794014
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
A study testing Conservative strategy and Aggressive strategy in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Conservative strategy and Aggressive strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Feb 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent vessel diameter stenosis > 75%
- Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test
- The reference diameter of both branches more than 2.3 mm by visual estimation
Who cannot join
- Cardiogenic shock
- ST-elevation myocardial infarction within 48 hours of symptom onset
- Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
- Graft vessels
- Patients who have to receive clopidogrel due to other conditions
- Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
Show all 11Show fewer
- Hypersensitivity to clopidogrel or aspirin
- Expectant survival less than 1 year
- Women who plan to become pregnant
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.
Read the detailed description
The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.
- Conditions
- Coronary Artery Disease
- Being tested
- Conservative strategy, Aggressive strategy
- 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.
Conservative strategyProcedure or surgery
- Main vessel stenting was performed.
- Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) >75% in LM subgroup.
- Side branch stenting was performed if TIMI flow <3 in the Side branch after ballooning in non-LM subgroup, and DS >50% or dissection in the Side branch after ballooning in LM subgroup.
Aggressive strategyProcedure or surgery
- Main vessel was performed.
- Side branch ballooning and kissing ballooning were done if DS >75% in the side branch after main vessel stenting in non-LM subgroup, and DS >50% in LM subgroup.
- Side branch stenting was performed if DS >50% in the side branch after ballooning in non-LM subgroup, and DS >30% or dissection in the side branch after ballooning in LM subgroup.
| Study group | Role | What they receive |
|---|---|---|
| Conservative strategy | Experimental | Not described Receives: Procedure: Conservative strategy |
| Aggressive strategy | Experimental | Not described Receives: Procedure: Aggressive strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure (TVF)
composite of cardiac death, myocardial infarction, target vessel revascularization
Measured: 12 months
Secondary outcomes (7)
Cardiac death
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Measured: 12 months
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 months
Target vessel revascularization (TVR)
TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.
Measured: 12 months
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 months
Stent thrombosis
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Measured: 12 months
Periprocedural enzyme elevation
Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.
Measured: during the hospitalization
the incidence of binary angiographic restenosis in the main branch and side branch
as measured by 9-month quantitative coronary analysis
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 258 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
- NCT00794014
- Sponsor's protocol ID
- 2007-08-073
- Status last verified
- Feb 2013
- First submitted
- 17 Nov 2008
- Last updated
- 13 Feb 2013
- Results posted
- No
Publications
Song YB, Park TK, Hahn JY, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Optimal Strategy for Provisional Side Branch Intervention in Coronary Bifurcation Lesions: 3-Year Outcomes of the SMART-STRATEGY Randomized Trial. JACC Cardiovasc Interv. 2016 Mar 28;9(6):517-26. doi: 10.1016/j.jcin.2015.11.037.
PubMed 27013152Song YB, Hahn JY, Song PS, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Randomized comparison of conservative versus aggressive strategy for provisional side branch intervention in coronary bifurcation lesions: results from the SMART-STRATEGY (Smart Angioplasty Research Team-Optimal Strategy for Side Branch Intervention in Coronary Bifurcation Lesions) randomized trial. JACC Cardiovasc Interv. 2012 Nov;5(11):1133-40. doi: 10.1016/j.jcin.2012.07.010.
PubMed 23174637Hahn JY, Song YB, Choi JH, Choi SH, Lee SY, Park HS, Hur SH, Lee S, Han KR, Rha SW, Cho BR, Park JS, Yoon J, Lim DS, Lee SH, Gwon HC; DATE Registry Investigators. Three-month dual antiplatelet therapy after implantation of zotarolimus-eluting stents: the DATE (Duration of Dual Antiplatelet Therapy AfterImplantation of Endeavor Stent) registry. Circ J. 2010 Nov;74(11):2314-21. doi: 10.1253/circj.cj-10-0347. Epub 2010 Oct 2.
PubMed 20938098
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
- ClinicalTrials.gov ID
- NCT00794014
- Acronym / sponsor ID
- 2007-08-073
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Nov 2008 (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.
The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.
Detailed description
The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative strategy | Experimental | Procedure: Conservative strategy |
| Aggressive strategy | Experimental | Procedure: Aggressive strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent vessel diameter stenosis > 75%
- Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test
- The reference diameter of both branches more than 2.3 mm by visual estimation
Key exclusion criteria (11 listed)
- Cardiogenic shock
- ST-elevation myocardial infarction within 48 hours of symptom onset
- Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
- Graft vessels
- Patients who have to receive clopidogrel due to other conditions
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 |
|---|---|---|
| Conservative strategy* Main vessel stenting was performed. * Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) >75% in LM subgroup. * Side branch stenting was performed if TIMI flow <3 in the Side branch after ballooning in non-LM subgroup, and DS >50% or dissection in the Side branch after ballooning in LM subgroup. | Procedure or surgery | Conservative strategy |
| Aggressive strategy* Main vessel was performed. * Side branch ballooning and kissing ballooning were done if DS >75% in the side branch after main vessel stenting in non-LM subgroup, and DS >50% in LM subgroup. * Side branch stenting was performed if DS >50% in the side branch after ballooning in non-LM subgroup, and DS >30% or dissection in the side branch after ballooning in LM subgroup. | Procedure or surgery | Aggressive strategy |
Primary outcome
Target vessel failure (TVF)
Time frame: 12 months
composite of cardiac death, myocardial infarction, target vessel revascularization
7 secondary outcomes
Cardiac death
Time frame: 12 months
Myocardial infarction (MI)
Time frame: 12 months
Target vessel revascularization (TVR)
Time frame: 12 months
Target lesion revascularization (TLR)
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
Periprocedural enzyme elevation
Time frame: during the hospitalization
the incidence of binary angiographic restenosis in the main branch and side branch
Time frame: 9 months
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 13 Feb 2013.
- Derived from this study: PubMed 27013152Song YB, Park TK, Hahn JY, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Optimal Strategy for Provisional Side Branch Intervention in Coronary Bifurcation Lesions: 3-Year Outcomes of the SMART-STRATEGY Randomized Trial. JACC Cardiovasc Interv. 2016 Mar 28;9(6):517-26. doi: 10.1016/j.jcin.2015.11.037.
- Derived from this study: PubMed 23174637Song YB, Hahn JY, Song PS, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Randomized comparison of conservative versus aggressive strategy for provisional side branch intervention in coronary bifurcation lesions: results from the SMART-STRATEGY (Smart Angioplasty Research Team-Optimal Strategy for Side Branch Intervention in Coronary Bifurcation Lesions) randomized trial. JACC Cardiovasc Interv. 2012 Nov;5(11):1133-40. doi: 10.1016/j.jcin.2012.07.010.
- Derived from this study: PubMed 20938098Hahn JY, Song YB, Choi JH, Choi SH, Lee SY, Park HS, Hur SH, Lee S, Han KR, Rha SW, Cho BR, Park JS, Yoon J, Lim DS, Lee SH, Gwon HC; DATE Registry Investigators. Three-month dual antiplatelet therapy after implantation of zotarolimus-eluting stents: the DATE (Duration of Dual Antiplatelet Therapy AfterImplantation of Endeavor Stent) registry. Circ J. 2010 Nov;74(11):2314-21. doi: 10.1253/circj.cj-10-0347. Epub 2010 Oct 2.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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 Conservative strategy and Aggressive strategy 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 3 inclusion and 11 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 13 Feb 2013. 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 vessel failure (TVF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794014, which also lists 3 linked publications.
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 13 Feb 2013.