Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)

Samsung Medical Center1 site in 1 country899 target enrollmentJanuary 2009

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Samsung Medical Center
Enrollment: 899
Locations: 1
Primary Endpoint: A composite of all cause death, MI, or any revascularization
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 intermediate lesions, we conducted the Conservative Revascularization versus Aggressive Revascularization for Coronary Stenting with Everolimus-Eluting Stents (SMART-CASE) trial.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

June 2016

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Hyeon-Cheol Gwon

Professor

Samsung Medical Center

Eligibility Criteria

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).