Coronary CT angiography versus standard follow-up after stent placement for high-risk patients

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

This trial will test whether using coronary CT angiography instead of usual follow-up care helps people at high risk after stent placement stay healthier.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3500 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (other)
• Locations: 22 sites (Bucheon-si and 21 other locations)
• Trial ID: NCT07009418 on ClinicalTrials.gov

What this trial studies

This interventional trial compares a follow-up strategy based on coronary CT angiography (CCTA) with standard care in patients considered high risk after successful percutaneous coronary intervention (PCI). Eligible patients have had contemporary drug-eluting stents or drug-coated balloons and meet predefined complex lesion or clinical high-risk criteria such as complex bifurcation, chronic total occlusion, left main PCI, long or multivessel lesions, diabetes on medication, dialysis-dependent renal failure, or multivascular disease. Participants are followed with the assigned surveillance approach and clinical outcomes are tracked to determine whether CCTA-based follow-up changes rates of adverse cardiovascular events. The goal is to identify whether a CCTA surveillance strategy can improve long-term prognosis above guideline-directed medical therapy and routine clinical follow-up.

Who should consider this trial

Good fit: Adults (≥19 years) who had a successful PCI with contemporary drug-eluting stents or drug-coated balloons and who meet at least one complex lesion or high-risk clinical criterion (for example complex bifurcation, CTO, left main PCI, long or multivessel disease, diabetes on medication, or dialysis-dependent renal disease).

Not a fit: Patients without complex lesions or high‑risk clinical features, or those who cannot undergo contrast CT (significant contrast allergy or other contraindication), are unlikely to benefit from this CCTA-based surveillance approach.

Why it matters

Potential benefit: If successful, routine CCTA follow-up could detect post-PCI problems earlier and reduce serious heart-related events or the need for repeat procedures in high-risk patients.

How similar studies have performed: Prior studies have shown CCTA can reliably detect structural or ischemic issues after PCI and has promising diagnostic utility, but randomized outcome data specifically in high-risk post-PCI populations remain limited.

Eligibility criteria

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.

Where this trial is running

Bucheon-si and 21 other locations

• 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)

Study contacts

• Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD

Conditions: Ischemic Heart Disease, Coronary Artery Disease, coronary artery disease, percutaneous coronary intervention, coronary computed tomography angiography, follow-up strategy