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

Recruiting now · Not applicable

Conditions studied: Ischemic Heart Disease, Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT07009418

Run by

Samsung Medical Center

People needed

3500

Starts

2025-10-02

Expected to finish

2032-12-31

Last updated by the study team

2025-12-19

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.
• 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.

You may not qualify if…

• 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.

Where it is running

• Kyungpook National University Hospital — Daegu, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Chonnam National University Hospital, Chonnam National University Medical School — Gwangju, South Korea
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea
• Inje University College of Medicine, Ilsan Paik Hospital — Ilsan, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Kwandong University Intl. ST. Mary's Hospital — Incheon, South Korea
• Jeonbuk National University Hospital — Jeonju, South Korea
• Gyeongsang National University Hospital — Jinju, South Korea
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Chung-Ang University Hospital, Chung-Ang University College of Medicine — Seoul, South Korea
• Ewha Womans University Seoul Hospital — Seoul, South Korea
• Hanyang University Seoul Hospital, College of Medicine, Hanyang University — Seoul, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• Korea University Kuro Hospital — Seoul, South Korea
• Kyung Hee University Medical Center — Seoul, South Korea
• Seoul National University Boramae Medical Center — Seoul, South Korea
• Ajou University Hospital — Suwon, South Korea
• Catholic University of Korea Uijeongbu St. Mary's Hospital — Uijeongbu-si, South Korea
• SoonChunHyang University Hospital Bucheon — Bucheon-si, South Korea
• Wonju Severance Christian Hospital — Wŏnju, South Korea
• Keimyung University Dongsan Medical Center — Daegu, South Korea

Full record on ClinicalTrials.gov

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