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
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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UNKNOWN
NA
899 participants
INTERVENTIONAL
2009-01-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
The aggressive group
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.
2
The conservative group
The conservative group
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.
The conservative group
Stenting was performed only in lesions with diameter stenosis \>70% and reference diameter (RD) ≥2.25 mm
Eligibility Criteria
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Inclusion Criteria
* Target lesion(s) must be located in a native coronary artery with diameter of ≥2.25 mm and ≤4.25 mm
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Hyeon-Cheol Gwon
Professor
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
Countries
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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.
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.
Other Identifiers
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2008-06-027
Identifier Type: -
Identifier Source: org_study_id