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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00743899
First received: August 27, 2008
Last updated: December 8, 2013
Last verified: December 2013

August 27, 2008
December 8, 2013
January 2009
June 2013   (final data collection date for primary outcome measure)
A composite of all cause death, MI, or any revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Patients-oriented composite outcomes, including all cause death, any myocardial infarction, and any revascularization by Academic Research Consortium Proposed Standard [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00743899 on ClinicalTrials.gov Archive Site
  • All cause Death [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and non-Q wave) [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
  • Any revascularization [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
  • Revascularization of target intermediate lesion [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  • Target vessel failure [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and non-Q wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (TVR) (all and ischemia-driven) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Compliance with dual antiplatelet therapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • 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.
  • Procedure: The conservative group
    Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm
  • Experimental: 1
    The aggressive group
    Intervention: Procedure: The aggressive group
  • Experimental: 2
    The conservative group
    Intervention: Procedure: The conservative group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
899
June 2016
June 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00743899
2008-06-027
Yes
Hyeon-Cheol Gwon, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
Samsung Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP