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
- Diseases
- Coronary artery disease
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SoonChunHyang University Hospital Bucheon Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Not yet recruiting |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Not yet recruiting |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chonnam National University Hospital, Chonnam National University Medical School Coordinator of this site? Confirm its status | Gwangju | South Korea | Not yet recruiting |
| Chung-Ang University Gwangmyeong Hospital Coordinator of this site? Confirm its status | Gwangmyeong | South Korea | Not yet recruiting |
| Inje University College of Medicine, Ilsan Paik Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Not yet recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Not yet recruiting |
| Kwandong University Intl. ST. Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Not yet recruiting |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Not yet recruiting |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Not yet recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Not yet recruiting |
| Korea University Kuro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Hanyang University Seoul Hospital, College of Medicine, Hanyang University Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Kyung Hee University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Chung-Ang University Hospital, Chung-Ang University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Not yet recruiting |
| Catholic University of Korea, Uijeongbu St. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Not yet recruiting |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.