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)

Resource links provided by NLM:


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
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014