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Clinical Trials in South Korea / NCT07009418
Recruiting Not applicable

Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE)

NCT07009418 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2025-10-02
Last updated
2025-12-19

Condition(s) studied

Ischemic Heart DiseaseCoronary Artery Disease

Investigational drug(s) / intervention(s)

Coronary CT Angiography (CCTA)

Coronary CT Angiography (CCTA): In the surveillance by CCTA group, patients will be evaluated by CCTA at 1 year from index hospitalization. CCTA will be done according to current acquisition guidelines. Downstream management according to the results from CCTA will be performed under recommendations from current guidelines.

Study summary

The aim of the SMART-CARE trial is to compare clinical outcomes between coronary CT angiography (CCTA) versus standard care as follow-up strategies in high-risk patients after percutaneous coronary intervention (PCI).

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: ① Patients aged 19 years old ② Patients who underwent successful PCI with one or more contemporary drug-eluting stents (stent diameter ≥3mm) or drug-coated balloons. ③ Patients must have at least one of the following criteria of complex coronary artery lesions or high-risk clinical characteristics: A. Complex coronary artery lesions: i. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size ii. Chronic total occlusion (≥3 months) as target lesion iii. PCI for unprotected left main (LM) disease (LM ostium, body, distal LM bifurcation including non-true bifurcation) iv. Long coronary lesions (used stents or drug-coated balloons ≥38 mm in length) v. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session) vi. Multiple devices needed (≥3 more stents or drug-coated balloons per patient) vii. In-stent restenosis lesion as target lesion viii. Severely calcified lesion (encircling calcium in angiography) ix. Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion B. High-risk clinical characteristics: i. Acute myocardial infarction (ST-elevation myocardial infarction \[MI\] or non-ST-elevation MI) with or without cardiogenic shock (SCAI Classification ≥C) at presentation ii. Diabetes mellitus which requires medical treatment (oral hypoglycemic agents or insulin) iii. End-stage renal disease under dialysis iv. Combined vascular disease other than coronary artery disease 1. Peripheral artery occlusive disease which is defined as A. Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or B. Previous limb or foot amputation for arterial vascular disease, or C. History of intermittent claudication and one or more of the following: 1) An ankle/arm blood pressure (BP) ratio \< 0.90, or 2) Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound, or D. Previous carotid revascularization or asymptomatic carotid artery stenosis ≥50% as diagnosed by duplex ultrasound or angiography. 2. Thoracoabdominal aortic disease which is defined as A. Documented thoracoabdominal aortic aneurysm by duplex ultrasound, angiography, or computed tomography angiography B. Previous endovascular or surgical treatment for thoracoabdominal aortic aneurysm ④ Subject who can verbally confirm understandings of risks, benefits and surveillance strategy alternatives of receiving CCTA and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: ① Advanced chronic kidney disease (Creatinine clearance \<30 ml/min/1.73 m2) not on dialysis * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) * Pregnancy or breast feeding ④ Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) ⑤ Unwillingness or inability to comply with the procedures described in this protocol.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
SoonChunHyang University Hospital Bucheon Bucheon-si South Korea Not Yet Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Not Yet Recruiting
Kyungpook National University Hospital Daegu South Korea Recruiting
Chonnam National University Hospital, Chonnam National University Medical School Gwangju South Korea Not Yet Recruiting
Chung-Ang University Gwangmyeong Hospital Gwangmyeong South Korea Not Yet Recruiting
Inje University College of Medicine, Ilsan Paik Hospital Ilsan South Korea Not Yet Recruiting
Gachon University Gil Medical Center Incheon South Korea Not Yet Recruiting
Kwandong University Intl. ST. Mary's Hospital Incheon South Korea Not Yet Recruiting
Jeonbuk National University Hospital Jeonju South Korea Not Yet Recruiting
Gyeongsang National University Hospital Jinju South Korea Not Yet Recruiting
Seoul National University Bundang Hospital Seongnam-si South Korea Not Yet Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Chung-Ang University Hospital, Chung-Ang University College of Medicine Seoul South Korea Not Yet Recruiting
Ewha Womans University Seoul Hospital Seoul South Korea Not Yet Recruiting
Hanyang University Seoul Hospital, College of Medicine, Hanyang University Seoul South Korea Not Yet Recruiting
Korea University Anam Hospital Seoul South Korea Not Yet Recruiting
Korea University Kuro Hospital Seoul South Korea Not Yet Recruiting
Kyung Hee University Medical Center Seoul South Korea Not Yet Recruiting
Seoul National University Boramae Medical Center Seoul South Korea Not Yet Recruiting
Ajou University Hospital Suwon South Korea Not Yet Recruiting
Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu-si South Korea Not Yet Recruiting
Wonju Severance Christian Hospital Wŏnju South Korea Not Yet Recruiting

More Samsung Medical Center trials in South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009418 on ClinicalTrials.gov ↗ ← All trials in South Korea