CT-FFR for Coronary In-stent Stenosis Based on ISR-Net Algorithm

NCT05131191 | Unknown DMC

• 1 other identifier: CT-FFR for in-stent lesion
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Stent Occlusion

Keywords

in-stent stenosis; CT derived fractional flow reserve; artificial intelligence; deep learning; image processing

Outcome Measures

Primary Outcomes (1)

• To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm.

  one month

Secondary Outcomes (1)

• To predict the functional accuracy of in stent lesions, PPV, NPV and area under ROC curve (AUC)

  one month

Study Arms (1)

patients with coronary metal stents implantation

Diagnostic Test: CT-FFR measurement; Procedure: invasive FFR

Interventions

CT-FFR measurement DIAGNOSTIC_TEST

Patients were scanned with ≥ 64 row CT according to standard operating specifications. The software obtains the coronary CT angiography image file through the data communication interface. Based on the image processing algorithm, the centerline and contour of the target vessel can be extracted, and then the target vessel can be reconstructed to obtain the three-dimensional size information of the vessel; Based on hydrodynamics calculation and analysis, the fractional flow reserve (FFR) of each position of the target vessel is measured.

Also known as: FFRCT

patients with coronary metal stents implantation

invasive FFR PROCEDURE

Insert the pressure guide wire into the finger guide tube and push the pressure guide wire until the pressure sensor just comes out of the orifice of guiding catheter; Equalize PD and PA values;Push the pressure guide wire to the distal end of the lesion, and record the measured blood vessel and position;Record the resting Pd / PA of the pressure guide wire;Nitroglycerin and adenosine triphosphate were administered intravenously according to standard catheter laboratory specifications to achieve maximum hyperemia;Record the FFR value of the in-stent lesions.

Also known as: pressure wire

patients with coronary metal stents implantation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients were implanted metal stents previously and had indications for coronary CTA test. The CT-FFR for in-stent lesions were evaluated based on Coronary CTA. Patients had the indication for invasive coronary angiography would be admitted in Cath lab and perform FFR measurement with pressure wire .

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• There are contraindications to the use of disodium adenosine triphosphate;
• Allergic to iodized contrast media;
• Pregnancy or unknown pregnancy status;
• The expected life is less than 2 months;
• The coronary artery image was obviously misplaced;
• Coronary artery occlusion.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, China

Location

Related Publications (6)

• Li Z, Zhang J, Xu L, Yang W, Li G, Ding D, Chang Y, Yu M, Kitslaar P, Zhang S, Reiber JHC, Arbab-Zadeh A, Yan F, Tu S. Diagnostic Accuracy of a Fast Computational Approach to Derive Fractional Flow Reserve From Coronary CT Angiography. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 1):172-175. doi: 10.1016/j.jcmg.2019.08.003. Epub 2019 Sep 18. No abstract available.

  PMID: 31542542 BACKGROUND

• Tang CX, Liu CY, Lu MJ, Schoepf UJ, Tesche C, Bayer RR 2nd, Hudson HT Jr, Zhang XL, Li JH, Wang YN, Zhou CS, Zhang JY, Yu MM, Hou Y, Zheng MW, Zhang B, Zhang DM, Yi Y, Ren Y, Li CW, Zhao X, Lu GM, Hu XH, Xu L, Zhang LJ. CT FFR for Ischemia-Specific CAD With a New Computational Fluid Dynamics Algorithm: A Chinese Multicenter Study. JACC Cardiovasc Imaging. 2020 Apr;13(4):980-990. doi: 10.1016/j.jcmg.2019.06.018. Epub 2019 Aug 14.

  PMID: 31422138 BACKGROUND

• Coenen A, Kim YH, Kruk M, Tesche C, De Geer J, Kurata A, Lubbers ML, Daemen J, Itu L, Rapaka S, Sharma P, Schwemmer C, Persson A, Schoepf UJ, Kepka C, Hyun Yang D, Nieman K. Diagnostic Accuracy of a Machine-Learning Approach to Coronary Computed Tomographic Angiography-Based Fractional Flow Reserve: Result From the MACHINE Consortium. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007217. doi: 10.1161/CIRCIMAGING.117.007217.

  PMID: 29914866 BACKGROUND

• Ko BS, Cameron JD, Munnur RK, Wong DTL, Fujisawa Y, Sakaguchi T, Hirohata K, Hislop-Jambrich J, Fujimoto S, Takamura K, Crossett M, Leung M, Kuganesan A, Malaiapan Y, Nasis A, Troupis J, Meredith IT, Seneviratne SK. Noninvasive CT-Derived FFR Based on Structural and Fluid Analysis: A Comparison With Invasive FFR for Detection of Functionally Significant Stenosis. JACC Cardiovasc Imaging. 2017 Jun;10(6):663-673. doi: 10.1016/j.jcmg.2016.07.005. Epub 2016 Oct 19.

  PMID: 27771399 BACKGROUND

• Coenen A, Lubbers MM, Kurata A, Kono A, Dedic A, Chelu RG, Dijkshoorn ML, van Geuns RJ, Schoebinger M, Itu L, Sharma P, Nieman K. Coronary CT angiography derived fractional flow reserve: Methodology and evaluation of a point of care algorithm. J Cardiovasc Comput Tomogr. 2016 Mar-Apr;10(2):105-13. doi: 10.1016/j.jcct.2015.12.006. Epub 2015 Dec 18.

  PMID: 26747231 BACKGROUND

• Fuchs A, Kuhl JT, Chen MY, Helqvist S, Razeto M, Arakita K, Steveson C, Arai AE, Kofoed KF. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography. J Cardiovasc Comput Tomogr. 2015 Sep-Oct;9(5):393-8. doi: 10.1016/j.jcct.2015.03.016. Epub 2015 Apr 16.

  PMID: 26091841 BACKGROUND

Study Officials

• Xue Yu, MD

  Beijing Hospital, National Center of Gerontology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: project manager

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)