This trial is active, not recruiting.

Condition coronary artery disease
Treatments the aggressive group, the conservative group
Sponsor Samsung Medical Center
Start date January 2009
End date June 2013
Trial size 899 participants
Trial identifier NCT00743899, 2008-06-027


The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
The aggressive group
the aggressive group
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 group
the conservative group
Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm

Primary Outcomes

A composite of all cause death, MI, or any revascularization
time frame: 1 year

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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).

Additional Information

Official title Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
Principal investigator Hyeon-Cheol Gwon, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Samsung Medical Center.