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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00743899
Other study ID # 2008-06-027
Secondary ID
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


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
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