Status:
UNKNOWN
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone
Lead Sponsor:
Samsung Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
899 Patients enrolled
Trial Details
Trial ID
NCT00743899
Start Date
January 1 2009
End Date
June 1 2016
Last Update
December 10 2013
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710