Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography Angiography
NCT Number: NCT06543641
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|Chronic Total Occlusion of Coronary Artery
Interventions: DIAGNOSTIC_TEST: Coronary computed tomography angiography|DIAGNOSTIC_TEST: Invasive coronary angiography
Sponsor: Lauri Mansikkaniemi
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-01-16
Completion Date: 2024-06-08
Locations: Helsinki University Central Hospital, Helsinki, Uusimaa, 00290, Finland

Summary:
The goal of this clinical trial is to assess third-generation dual-source coronary computed tomography angiography (CCTA) performance in the evaluation of long coronary stents in patients with coronary artery chronic total occlusions. The main questions it aims to answer are:

* Can patency of long coronary artery stents be assessed with third generation CCTA?
* What are the factors affecting the assessability?
* What is the radiation exposure of third generation CCTA?

Primary Outcome Measures: Stent patency assesment with third-generation dual-source CCTA, Assessability of stent patency with third-generation dual-source CCTA in long coronary artery chronic total occlusion stents. CCTA results were divided into three categories: 1) negative (\<50% stent luminal narrowing), 2) ISR (\> 50% stent luminal narrowing) or 3) inconclusive (CCTA was not able to define the degree of stent luminal narrowing). Patients with ISR or inconclusive result were considered as CCTA positive. Confirmation imaging was conducted with ICA, if necessary. Positive predictive value, negative predictive value, sensitivity and specificity were calculated., up to 7.3 months (maximum time between CCTA and ICA)
Secondary Outcome Measures: To determine significant differences in distribution of patient- and lesion-related characteristics in third-generation dual-source CCTA negative versus positive patient groups., Patient-related characteristics assessed: age, body mass index, sex, smoking history, medical conditions at CTO PCI (diabetes, insulin required diabetes, heart failure, peripheral artery disease, dyslipidemia, hypertension, pulmonary disease, chronic kidney disease, atrial fibrillation, cardiac pacemaker, prior myocardial infarction, prior stroke, prior PCI, prior CABG), double-CTO (two treated CTO:s in one procedure), coronary artery dominance (RCA, LCX or balanced), a non-CTO stent implanted in the CTO PCI procedure, clinical presentation (stable or acute), CCTA Agatston calcium score.

Lesion-related characteristics assessed: stented vessel (RCA, LAD, LCX), Japanese-CTO score (objective index of CTO procedure difficulty), long CTO stent parameters (number of consecutive stents, total stent length, stent length in lesions stented with a single stent, stent length in lesions stented with multiple stents, stent diameter), duration of the follow-up since stent implantation., through study completion, average of 1 year|To compare radiation exposure of third-generation dual-source CCTA to ICA, measured as effective dose, in patients receiving both examinations., Radiation exposure of third-generation dual-source CCTA (dose length product (DLP), milligray\*cm) and radiation exposure of ICA (dose area product (DAP), gray\*cm2) were converted to effective dose (millisievert, mSv) and compared., from CCTA to possible ICA, up two 7.3 months