Coronary Stent OcclusionNCT05131191

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

An observational study of Coronary Stent Occlusion, run by Beijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Coronary Stent Occlusion
What is being tested?: CT-FFR measurement and invasive FFR
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 150 participants
Where: 1 siteChina
Study dates: 1 Jan 2022to 1 Jun 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

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 .

Who may be able to join

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.

Who cannot join

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);
There are contraindications to the use of disodium adenosine triphosphate;

Show all 13Show fewer

Allergic to iodized contrast media;
Pregnancy or unknown pregnancy status;
The expected life is less than 2 months;
There are any other factors that the researchers believe are not suitable for inclusion or completion of this study.
CTA image exclusion criteria:
The coronary artery image was obviously misplaced;
Coronary artery occlusion.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Hospital
Beijing

Other trials in China

About this study

Official title: Application of New Algorithm ISR-Net in Measuring CT-FFR of Coronary In-stent Stenosis.

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.

Read the detailed description

CT-FFR is an important noninvasive examination to evaluate the function of coronary artery disease. It can help clinicians make clinical decisions and reduce patients' invasive coronary angiography (ICA). The image quality of coronary CT angiography (CCTA) is the basis of CT-FFR measurement. Because metal stents seriously interfere with the imaging of CCTA, it is very difficult to measure the CT-FFR value of lesions in stents. However, a large number of patients need imaging follow-up evaluation after stenting. In the previous research, the investigators creatively invented a new algorithm ISR-Net and conducted a retrospective analysis. It is preliminarily proved that the algorithm can more accurately display the stenosis lesions in the stent than the previous imaging software, making it possible to calculate the CT-FFR of the lesions in the stent. At present, the algorithm has applied for a national invention patent. In order to transform to clinical application, further clinical verification is needed. This study will evaluate the accuracy of ISR-Net algorithm in assessing the function of coronary stent stenosis by carrying out prospective clinical trials and taking the blood flow reserve fraction (FFR) measured by pressure wire as the gold standard. At the same time, the standard process of CT-FFR measurement of in stent lesions was established. The research results are of great significance to solve the bottleneck problem of CT-FFR and expand its application scope.

Conditions: Coronary Stent Occlusion
Being tested: CT-FFR measurement, invasive FFR
Keywords: in-stent stenosis, CT derived fractional flow reserve, artificial intelligence, deep learning, image processing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-FFR measurementDiagnostic test
Also called FFRCT
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.
invasive FFRProcedure or surgery
Also called pressure wire
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.

Study groups in NCT05131191
Study group	Role	What they receive
patients with coronary metal stents implantation		Not described Receives: Diagnostic Test: CT-FFR measurement; Procedure: invasive FFR

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20221 Jun 2024

First posted23 Nov 2021
Study start1 Jan 2022
Primary completion1 Jan 2024 (estimated)
Study completion1 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Coronary Stent OcclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05131191
Sponsor's protocol ID: CT-FFR for in-stent lesion
Status last verified: Feb 2023
First submitted: 11 Nov 2021
Last updated: 8 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31542542
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.
PubMed 31422138
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.
PubMed 29914866
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.
PubMed 27771399
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.
PubMed 26747231
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.
PubMed 26091841

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of New Algorithm ISR-Net in Measuring CT-FFR of Coronary In-stent Stenosis.
ClinicalTrials.gov ID: NCT05131191
Acronym / sponsor ID: CT-FFR for in-stent lesion
Conditions: Coronary Stent Occlusion
Keywords: in-stent stenosis, CT derived fractional flow reserve, artificial intelligence, deep learning, image processing
Study type: Observational
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Beijing HospitalOther government
Study start: 1 Jan 2022 (actual)
Primary completion: 1 Jan 2024 (estimated)
Study completion: 1 Jun 2024 (estimated)
First posted: 23 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
patients with coronary metal stents implantation	–	Diagnostic Test: CT-FFR measurement, Procedure: invasive FFR

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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 .

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-FFR measurementAlso: FFRCTPatients 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.	Diagnostic test	patients with coronary metal stents implantation
invasive FFRAlso: pressure wireInsert 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.	Procedure or surgery	patients with coronary metal stents implantation

Primary outcome

To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm.
Time frame: one month

1 secondary outcome

To predict the functional accuracy of in stent lesions, PPV, NPV and area under ROC curve (AUC)
Time frame: one month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Background: PubMed 31542542Li 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.
Background: PubMed 31422138Tang 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.
Background: PubMed 29914866Coenen 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.
Background: PubMed 27771399Ko 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.
Background: PubMed 26747231Coenen 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.
Background: PubMed 26091841Fuchs 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xue Yu, MD study chair

Beijing Hospital, National Center of Gerontology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Stent Occlusion, run by Beijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm. (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05131191, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.