Clinical trial NCT00743899: Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone
Official title: Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Everolimus-eluting stent
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 899
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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).

Primary outcomes:
measure: A composite of all cause death, MI, or any revascularization
timeFrame: 1 year
Secondary outcomes:
measure: All cause Death
timeFrame: 1 years
measure: Cardiac death
timeFrame: 1 years
measure: Myocardial infarction (Q-wave and non-Q wave)
timeFrame: 1 years
measure: Any revascularization
timeFrame: 1 years
measure: Stent thrombosis
timeFrame: 1 years
measure: Revascularization of target intermediate lesion
timeFrame: 1 years
measure: Target vessel failure
timeFrame: 1 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.