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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
  Purpose

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


Condition Intervention
Coronary Artery Disease
Procedure: The aggressive group
Procedure: The conservative group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • A composite of all cause death, MI, or any revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 899
Study Start Date: January 2009
Estimated Study Completion Date: June 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00743899     History of Changes
Other Study ID Numbers: 2008-06-027
Study First Received: August 27, 2008
Last Updated: December 8, 2013
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014