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NCT07009418Recruiting

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

Coronary Computed Tomography Angiography Versus Standard Care in High-Risk Patients After Percutaneous Coronary Intervention

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
3500 (estimated)
First submitted
29 May 2025
Start date
2 Oct 2025
Primary completion date
31 Dec 2031
Lead sponsor
Samsung Medical Center
NCT number
NCT07009418

What you commit to

  • Study type: Interventional
  • Planned participants: 3500
  • From 2 Oct 2025 to the primary completion date, 31 Dec 2031
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Lab values

  • ① Advanced chronic kidney disease (Creatinine clearance \<30 ml/min/1.73 m2) not on dialysis

Who the study is looking for

  • 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:
  • Complex coronary artery lesions:
  • 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
  • High-risk clinical characteristics:
  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SoonChunHyang University Hospital Bucheon
Coordinator of this site? Confirm its status
Bucheon-siSouth KoreaNot yet recruiting
Keimyung University - Dongsan Medical Center
Coordinator of this site? Confirm its status
DaeguSouth KoreaNot yet recruiting
Kyungpook National University Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaRecruiting
Chonnam National University Hospital, Chonnam National University Medical School
Coordinator of this site? Confirm its status
GwangjuSouth KoreaNot yet recruiting
Chung-Ang University Gwangmyeong Hospital
Coordinator of this site? Confirm its status
GwangmyeongSouth KoreaNot yet recruiting
Inje University College of Medicine, Ilsan Paik Hospital
Coordinator of this site? Confirm its status
IlsanSouth KoreaNot yet recruiting
Gachon University Gil Medical Center
Coordinator of this site? Confirm its status
IncheonSouth KoreaNot yet recruiting
Kwandong University Intl. ST. Mary's Hospital
Coordinator of this site? Confirm its status
IncheonSouth KoreaNot yet recruiting
jeonbuk National University Hospital
Coordinator of this site? Confirm its status
JeonjuSouth KoreaNot yet recruiting
Gyeongsang National University Hospital
Coordinator of this site? Confirm its status
JinjuSouth KoreaNot yet recruiting
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaNot yet recruiting
Korea University Kuro Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Seoul National University Boramae Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Korea University Anam Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Ewha Womans University Seoul Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Kyung Hee University Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Chung-Ang University Hospital, Chung-Ang University College of Medicine
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Ajou University Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaNot yet recruiting
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Coordinator of this site? Confirm its status
Uijeongbu-siSouth KoreaNot yet recruiting
Wonju Severance Christian Hospital
Coordinator of this site? Confirm its status
WŏnjuSouth KoreaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.