NCT00743899

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
899

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

4.4 years

First QC Date

August 27, 2008

Last Update Submit

December 8, 2013

Conditions

Coronary Artery Disease

Keywords

Angioplasty, Transluminal, Percutaneous CoronaryEverolimus-eluting stent

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (7)

  • All cause Death

    1 years

  • Cardiac death

    1 years

  • Myocardial infarction (Q-wave and non-Q wave)

    1 years

  • Any revascularization

    1 years

  • Stent thrombosis

    1 years

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

The aggressive group

Procedure: The aggressive group

2

EXPERIMENTAL

The conservative group

Procedure: The conservative group

Interventions

The aggressive groupPROCEDURE

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.

1
The conservative groupPROCEDURE

Stenting was performed only in lesions with diameter stenosis \>70% and reference diameter (RD) ≥2.25 mm

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (2)

  • Kim J, Lim SH, Hahn JY, Jeong JO, Park YH, Chun WJ, Oh JH, Cho DK, Choi YJ, Im ES, Won KH, Lee SY, Kim SW, Choi KH, Lee JM, Park TK, Yang JH, Song YB, Choi SH, Gwon HC. Outcomes of Deferring Percutaneous Coronary Intervention Without Physiologic Assessment for Intermediate Coronary Lesions. Korean Circ J. 2025 Mar;55(3):185-195. doi: 10.4070/kcj.2023.0223. Epub 2024 Dec 2.

    PMID: 39962964DERIVED

  • 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.

    PMID: 28363687DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hyeon-Cheol Gwon, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 29, 2008

Study Start

January 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2016

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

KR(1)