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

December 8, 2013 updated by: Hyeon-Cheol Gwon, Samsung Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

899

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
The aggressive group
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.
Experimental: 2
The conservative group
Procedure: The conservative group
Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite of all cause death, MI, or any revascularization
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Hyeon-Cheol Gwon, MD,PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 8, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-06-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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