Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone

NCT ID: NCT00743899

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

899 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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Angioplasty, Transluminal, Percutaneous Coronary Everolimus-eluting stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

The aggressive group

Group Type EXPERIMENTAL

The aggressive group

Intervention Type PROCEDURE

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.

2

The conservative group

Group Type EXPERIMENTAL

The conservative group

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

The conservative group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyeon-Cheol Gwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyeon-Cheol Gwon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 39962964 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28363687 (View on PubMed)

Other Identifiers

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2008-06-027

Identifier Type: -

Identifier Source: org_study_id