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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
The aggressive group
The conservative group
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angioplasty, Transluminal, Percutaneous Coronary, Everolimus-eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

The aggressive group

The conservative group

Outcomes

Primary Outcome Measures

A composite of all cause death, MI, or any revascularization

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2008
Last Updated
December 8, 2013
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00743899
Brief Title
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone
Acronym
SMART-CASE
Official Title
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Everolimus-eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
899 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The aggressive group
Arm Title
2
Arm Type
Experimental
Arm Description
The conservative group
Intervention Type
Procedure
Intervention Name(s)
The aggressive group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
The conservative group
Intervention Description
Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm
Primary Outcome Measure Information:
Title
A composite of all cause death, MI, or any revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All cause Death
Time Frame
1 years
Title
Cardiac death
Time Frame
1 years
Title
Myocardial infarction (Q-wave and non-Q wave)
Time Frame
1 years
Title
Any revascularization
Time Frame
1 years
Title
Stent thrombosis
Time Frame
1 years
Title
Revascularization of target intermediate lesion
Time Frame
1 years
Title
Target vessel failure
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28363687
Citation
Hahn JY, Choi SH, Jeong JO, Song YB, Choi JH, Park YH, Chun WJ, Oh JH, Cho DK, Lim SH, Choi YJ, Im ES, Won KH, Lee SY, Kim SW, Gwon HC. Conservative versus aggressive treatment strategy with angiographic guidance alone in patients with intermediate coronary lesions: The SMART-CASE randomized, non-inferiority trial. Int J Cardiol. 2017 Aug 1;240:114-119. doi: 10.1016/j.ijcard.2017.03.075. Epub 2017 Mar 18.
Results Reference
derived

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

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