CT-FFR for Coronary In-stent Stenosis Based on ISR-Net Algorithm (NCT05131191) | Clinical Trial Compass
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CT-FFR for Coronary In-stent Stenosis Based on ISR-Net Algorithm
China150 participantsStarted 2022-01-01
Plain-language summary
CT-FFR(CT-derived flow reserve fraction) usually could not been measured accurately for in-stent lesions due to the serious interference with the metal structs. ISR-Net is a new algorithm in assessing the flow of coronary in-stent stenosis. We compare the CT-FFR value of in-stent lesions with the invasive FFR measured by pressure wire to evaluate the accuracy of ISR-Net algorithm. The research results are of great significance to solve the bottleneck problem of CT-FFR and expand its application scope.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General Inclusion Criteria:
* Over 18 years old;
* Be able to understand the purpose of the test and sign the informed consent form;
* Previous intracoronary stent implantation;
* According to the comprehensive clinical evaluation, coronary angiography and FFR were proposed;
CTA image Inclusion Criteria:
* The coronary CT angiography images showed that the reference vessel diameter of the stenosis segment in the stent was ≥ 2mm;
* The stenosis degree of coronary stent diameter ≥ 30% and ≤ 90% by visual inspection.
Exclusion Criteria:
General exclusion criteria:
* Previous coronary artery bypass grafting (CABG), artificial heart valve implantation, pacemaker or implantable defibrillator implantation;
* There are persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure state (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA cardiac function grade III or IV) or acute pulmonary edema;
* Acute myocardial infarction occurred within 7 days before enrollment;
* Patients with other severe diseases are not suitable for clinical trials, such as complex congenital heart history, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease, chronic renal function impairment (serum creatinine value \> 1.5 mg / dL or creatinine clearance rate \< 45ml / kg · 1.73m2…
What they're measuring
1
To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm.