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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kyungpook National University Hospital
  Daegu, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• SoonChunHyang University Hospital Bucheon
  Bucheon-si, South Korea Not yet recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Not yet 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

Study contacts

• Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD
• Email: drone80@hanmail.net
• Phone: +82234102575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.