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

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ClinicalTrials.gov Identifier: NCT00743899
Recruitment Status : Unknown
Verified December 2013 by Hyeon-Cheol Gwon, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2008
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: The aggressive group Procedure: The conservative group

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 899 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
Study Start Date : January 2009
Primary Completion Date : June 2013
Estimated Study Completion Date : June 2016
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. A composite of all cause death, MI, or any revascularization [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. All cause Death [ Time Frame: 1 years ]
  2. Cardiac death [ Time Frame: 1 years ]
  3. Myocardial infarction (Q-wave and non-Q wave) [ Time Frame: 1 years ]
  4. Any revascularization [ Time Frame: 1 years ]
  5. Stent thrombosis [ Time Frame: 1 years ]
  6. Revascularization of target intermediate lesion [ Time Frame: 1 years ]
  7. Target vessel failure [ Time Frame: 1 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743899


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
More Information

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00743899     History of Changes
Other Study ID Numbers: 2008-06-027
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
Angioplasty, Transluminal, Percutaneous Coronary
Everolimus-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases