Coronary Artery Disease Clinical Trial
— SMART-CASEOfficial title:
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
Verified date | December 2013 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.
Status | Active, not recruiting |
Enrollment | 899 |
Est. completion date | June 2016 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A composite of all cause death, MI, or any revascularization | 1 year | Yes | |
Secondary | All cause Death | 1 years | Yes | |
Secondary | Cardiac death | 1 years | Yes | |
Secondary | Myocardial infarction (Q-wave and non-Q wave) | 1 years | Yes | |
Secondary | Any revascularization | 1 years | No | |
Secondary | Stent thrombosis | 1 years | Yes | |
Secondary | Revascularization of target intermediate lesion | 1 years | No | |
Secondary | Target vessel failure | 1 years | Yes |
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