Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Procedure: The aggressive group; Procedure: The conservative group

• Registration Number: NCT00743899
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2009-01
• Primary Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-08
• Last Update Posted: 2013-12-10
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 899

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	The aggressive group	The aggressive group
2	The conservative group	The conservative group

Primary Outcome Measures

Name	Time	Method
A composite of all cause death, MI, or any revascularization	1 year

Secondary Outcome Measures

Name	Time	Method
Any revascularization	1 years
Target vessel failure	1 years
Cardiac death	1 years
Myocardial infarction (Q-wave and non-Q wave)	1 years
Stent thrombosis	1 years
All cause Death	1 years
Revascularization of target intermediate lesion	1 years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of