Coronary Artery DiseaseSMART-CASENCT00743899
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone
A study testing The aggressive group and The conservative group in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone. 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?
- The aggressive group and The conservative group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 899 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jun 2016
- 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
- Intermediate coronary lesion(s) (diameter stenosis between 50% and 70% by quantitative coronary analysis)
- Target lesion(s) must be located in a native coronary artery with diameter of ≥2.25 mm and ≤4.25 mm
Who cannot join
- cardiogenic shock
- myocardial infarction (MI) within 48 hours
- left main lesion
- drug-eluting stent implantation in the target vessel prior to enrollment
- ≥2 chronic total occlusions in major coronary territories
- history of bleeding diathesis or known coagulopathy
Show all 10Show fewer
- gastrointestinal or genitourinary bleeding within 3 months or major surgery within 2 months
- platelet count <100,000 cells/mm3
- planned elective surgical procedure that would necessitate interruption of thienopyridine during the first 6 months after enrollment
- non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.
Read the detailed description
To investigate whether conservative revascularization using criteria of 70% diameter stenosis would be non-inferior to aggressive revascularization using criteria of 50% diameter stenosis in coronary intermediate lesions, we conducted the Conservative Revascularization versus Aggressive Revascularization for Coronary Stenting with Everolimus-Eluting Stents (SMART-CASE) trial.
- Conditions
- Coronary Artery Disease
- Being tested
- The aggressive group, The conservative group
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Everolimus-eluting stent
- 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.
The aggressive groupProcedure or surgery
Stents were implanted in lesions with diameter stenosis >50% and RD ≥2.25 mm and balloon angioplasty was performed in lesions with diameter stenosis >50% and RD ≥2.0 mm and <2.25 mm.
The conservative groupProcedure or surgery
Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The aggressive group Receives: Procedure: The aggressive group |
| 2 | Experimental | The conservative group Receives: Procedure: The conservative group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of all cause death, MI, or any revascularization
Measured: 1 year
Secondary outcomes (7)
All cause Death
Measured: 1 years
Cardiac death
Measured: 1 years
Myocardial infarction (Q-wave and non-Q wave)
Measured: 1 years
Any revascularization
Measured: 1 years
Stent thrombosis
Measured: 1 years
Revascularization of target intermediate lesion
Measured: 1 years
Target vessel failure
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2013
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 899 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
- NCT00743899
- Sponsor's protocol ID
- 2008-06-027
- Acronym
- SMART-CASE
- Status last verified
- Dec 2013
- First submitted
- 27 Aug 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim J, Lim SH, Hahn JY, Jeong JO, Park YH, Chun WJ, Oh JH, Cho DK, Choi YJ, Im ES, Won KH, Lee SY, Kim SW, Choi KH, Lee JM, Park TK, Yang JH, Song YB, Choi SH, Gwon HC. Outcomes of Deferring Percutaneous Coronary Intervention Without Physiologic Assessment for Intermediate Coronary Lesions. Korean Circ J. 2025 Mar;55(3):185-195. doi: 10.4070/kcj.2023.0223. Epub 2024 Dec 2.
PubMed 39962964Hahn JY, Choi SH, Jeong JO, Song YB, Choi JH, Park YH, Chun WJ, Oh JH, Cho DK, Lim SH, Choi YJ, Im ES, Won KH, Lee SY, Kim SW, Gwon HC. Conservative versus aggressive treatment strategy with angiographic guidance alone in patients with intermediate coronary lesions: The SMART-CASE randomized, non-inferiority trial. Int J Cardiol. 2017 Aug 1;240:114-119. doi: 10.1016/j.ijcard.2017.03.075. Epub 2017 Mar 18.
PubMed 28363687
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
- ClinicalTrials.gov ID
- NCT00743899
- Acronym / sponsor ID
- SMART-CASE / 2008-06-027
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Everolimus-eluting stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 Aug 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 aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.
Detailed description
To investigate whether conservative revascularization using criteria of 70% diameter stenosis would be non-inferior to aggressive revascularization using criteria of 50% diameter stenosis in coronary intermediate lesions, we conducted the Conservative Revascularization versus Aggressive Revascularization for Coronary Stenting with Everolimus-Eluting Stents (SMART-CASE) trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: The aggressive groupThe aggressive group |
| 2 | Experimental | Procedure: The conservative groupThe conservative group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intermediate coronary lesion(s) (diameter stenosis between 50% and 70% by quantitative coronary analysis)
- Target lesion(s) must be located in a native coronary artery with diameter of ≥2.25 mm and ≤4.25 mm
Key exclusion criteria (10 listed)
- cardiogenic shock
- myocardial infarction (MI) within 48 hours
- left main lesion
- drug-eluting stent implantation in the target vessel prior to enrollment
- ≥2 chronic total occlusions in major coronary territories
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 |
|---|---|---|
| The aggressive groupStents were implanted in lesions with diameter stenosis >50% and RD ≥2.25 mm and balloon angioplasty was performed in lesions with diameter stenosis >50% and RD ≥2.0 mm and <2.25 mm. | Procedure or surgery | 1 |
| The conservative groupStenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm | Procedure or surgery | 2 |
Primary outcome
A composite of all cause death, MI, or any revascularization
Time frame: 1 year
7 secondary outcomes
All cause Death
Time frame: 1 years
Cardiac death
Time frame: 1 years
Myocardial infarction (Q-wave and non-Q wave)
Time frame: 1 years
Any revascularization
Time frame: 1 years
Stent thrombosis
Time frame: 1 years
Revascularization of target intermediate lesion
Time frame: 1 years
Target vessel failure
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Derived from this study: PubMed 39962964Kim J, Lim SH, Hahn JY, Jeong JO, Park YH, Chun WJ, Oh JH, Cho DK, Choi YJ, Im ES, Won KH, Lee SY, Kim SW, Choi KH, Lee JM, Park TK, Yang JH, Song YB, Choi SH, Gwon HC. Outcomes of Deferring Percutaneous Coronary Intervention Without Physiologic Assessment for Intermediate Coronary Lesions. Korean Circ J. 2025 Mar;55(3):185-195. doi: 10.4070/kcj.2023.0223. Epub 2024 Dec 2.
- Derived from this study: PubMed 28363687Hahn JY, Choi SH, Jeong JO, Song YB, Choi JH, Park YH, Chun WJ, Oh JH, Cho DK, Lim SH, Choi YJ, Im ES, Won KH, Lee SY, Kim SW, Gwon HC. Conservative versus aggressive treatment strategy with angiographic guidance alone in patients with intermediate coronary lesions: The SMART-CASE randomized, non-inferiority trial. Int J Cardiol. 2017 Aug 1;240:114-119. doi: 10.1016/j.ijcard.2017.03.075. Epub 2017 Mar 18.
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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 The aggressive group and The conservative group 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Dec 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?
Results are not available in the source record.
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?
A composite of all cause death, MI, or any revascularization (time frame: 1 year). 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 NCT00743899, which also lists 2 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 10 Dec 2013.