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

Coronary Artery Disease Clinical Trial

— SMART-CASE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00743899
• Other study ID #: 2008-06-027
• Status: Active, not recruiting
• Phase: N/A
• First received: August 27, 2008
• Last updated: December 8, 2013
• Start date: January 2009
• Est. completion date: June 2016

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• 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
Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) =2.25 mm

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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