Stable AnginaAutocathFFRNCT04861519
Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device
An observational study of Stable Angina and Unstable Angina, run by Medhub Ltd. at 3 sites in Israel.
Trial summary
Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, NSTEMI
- What is being tested?
- Collecting invasive FFR measurements.
- How many people
- 308 participants
- Where
- 3 sitesIsrael
- Study dates
- 9 May 2021to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: C-Arm images from adult subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured in vessels with coronary lesions.
Who may be able to join
- patient specific:
- Age > 18 years.
- Subjects with stable angina pectoris, unstable angina pectoris or NSTEM1 and in whom invasive FFR was performed to assess a non-culprit stenosis in at least one coronary artery.
- Angiographic:
- Subject underwent a clinically indicated Invasive Coronary Angiogram (ICA).
- Subject underwent invasive FFR with IV or intracoronary Adenosine, Adenosine Triphosphate (ATP) or Papaverine used as hyperemic stimulus.
Who cannot join
- Patient Specific:
- Angiogram not obtained on an FDA cleared C-Arm angiography system.
- Invasive FFR not obtained on an FDA cleared FFR catheter tip pressure transducer (a.k.a. pressure wire).
- Vessel size less than 2 mm.
- Subject presents with an acute infarct (STEM1) OR has documented prior STEMI on same side (right/left).
- CTO in target vessel.
Show all 20Show fewer
- Prior CABG, heart transplant or valve surgery, prior TAVI/TAVR or severe left sided valvular disease.
- Known LVEF ≤45%.
- Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
- TIMI Grade 2 or lower at baseline.
- Target lesion involves Left Main (stenosis >50%).
- PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis.
- Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
- Target coronary vessel provides collaterals to a chronically occluded vessel.
- Angiographic:
- Coronary angiography was performed per standard of care at a cine frame rate of at least 7 frames per second.
- Presence of aortic damping.
- Distortion of the waveform.
- A minimum of two different angiographic views for each lesion of interest in the Left Circumflex Artery (LCX), Left Descending Artery (LAD) and in the Right Circumflex Artery (RCA).
- Lesion is not clearly visible.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Soroka Medical Center
Beersheba, South
Hillel Yaffe Medical Center
Hadera, Central District
Rambam Medical Center
Haifa, North
About this study
Official title: Pivotal, Single-arm Clinical Trial (Prospective Analysis of Retrospective Data) to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device in Measuring FFR From Digital Angiography Images as a Supportive Aid in the Evaluation and Assessment of Hemodynamically Significant Coronary Artery Disease
Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined intuitively and based on the physician eyeball. By using real-world historical data of invasive FFR, the analysis of the obtained data can ensure that the study results are expected to include invasive FFR results that are in the grey zone, when invasive FFR is used in real life and represent the real expected use of the product. Furthermore, the analysis of the data obtained in the studies with these similar devices measuring FFR obtained from angiograms was actually performed in a retrospective manner. That is, although the angiographic images and pressure wire recordings were obtained in real-time, due to the need to mark the vessel in real-time and obtain specific projections during the procedure without which the FFR cannot be calculated, the primary endpoint (sensitivity and specificity) and accuracy were determined in all studies by a post-hoc review by a similar independent QCA core laboratory. The invasive FFR data, as well as the software generated FFR data were reviewed post-hoc by a core laboratory or even at the company.
Read the detailed description
The proposed study is designed to compare MedHub AutocathFFR measurements obtained from angiograms for the non-invasive determination of the presence of hemodynamically significant coronary lesions. The software device will run on angiograms generated during cardiac catheterization and results will be compared to invasive FFR measurements.
The study is a prospective (analysis of retrospective data), multi-center, observational, single-arm, study.
A total of 308 cases will be enrolled in the study. The study population who represent the target population for this procedure consists of subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and for whom invasive FFR have been measured in vessels with coronary lesions. For each lesion of interest, a minimum of two 2D angiographic projections, will be obtained. Patients of both genders, all ethnicities, >18 years of age will be recruited to the study. Study cases will be sourced from numerous hospitals in the United States and Israel.
Investigators will screen cases based on the inclusion/exclusion criteria described below. General patient demographics, medical history, concomitant medications, C-arm angiography system used, FFR pressure wire used, etc., will be obtained for each study case.
Subjects with known or suspected coronary artery disease who were scheduled for clinically indicated invasive coronary angiography (ICA) and on whom invasive FFR has been measured in vessels with coronary lesions will comprise the patient population. Coronary angiography will have been performed in a routine fashion in patients with suspected coronary artery disease. When clinically indicated, invasive FFR will have been measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus.
The patient's angiographic images will be sent to an independent Quantitative Coronary Arteriography (QCA) Core Laboratory, where they will be processed using the MedHub AutocathFFR device, by independent potential users of the device (i.e., interventional cardiologists). The users will use the diagnostic angiograms and upload them to the AutocathFFR device, to generate the AutocathFFR value. The independent users will be blinded to the software device-generated FFR results and to the invasive FFR measurements. Blinding will be employed in the study because the primary endpoint, i.e., the scored FFR measurements per vessel are subject to bias by device users. Observations in patients with more than 1 study vessel will be presumed independent. The AutocathFFR will not be used for diagnostic or clinical decisions. A detailed standard operating procedure (SOP) for AutoCathFFR computation will be provided to the QCA Core Laboratory.
The AutocathFFR device automatically suggests and marks locations of suspicious narrowing and computes an FFR value for each detected area. The clinician can also select and mark manually locations with suspected narrowing for computing of FFR value. The clinical performance of AutocathFFR device depends only on the uploaded angiograms, on which the AutocathFFR results are presented alongside the viewed blood vessel. There is no need for user interaction with the system during the diagnostic angiography procedure. For example, there is no need to take specific orthogonal projection nor to designate or mark the blood vessels or segments. When the desired coronary artery is viewed on the Cath Lab monitor, the AutocathFFR measurement is automatically shown alongside the viewed vessel, if an area of narrowing is identified in the vessel. Therefore, the use of the AutocathFFR device is seamless with the angiographic imaging procedure and does not require any additional intervention by the cardiologist.
- Conditions
- Stable Angina, Unstable Angina, NSTEMI
- Being tested
- Collecting invasive FFR measurements.
- Keywords
- coronary angiography
- Medical subject headings
- Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting invasive FFR measurements.Other
Also called data collection
Invasive FFR measurements from the patient's hospital records will be collected.
| Study group | Role | What they receive |
|---|---|---|
| adult subjects who underwent a clinically indicated invasive coronary angiography | adult subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured in vessels with coronary lesions. Receives: Other: Collecting invasive FFR measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of AutoCathFFR
Co-primary endpoints are the sensitivity and specificity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR > 0.80 is considered "negative".
Measured: Up to 2 months
Secondary outcomes (7)
To assess the accuracy
To assess the accuracy, positive predictive value and negative predictive value and per lesion of the AutocathFFR in correctly diagnosing both positive, as well as negative hemodynamically significant coronary stenosis, using the invasive FFR as the reference standard.
Measured: Up to 2 months
To assess the corelation bwtween invasive FFR and AutoCathFFR
To assess continuously scored AutocathFFR overall correlation with the invasive FFR measurements
Measured: Up to 2 months
To assess the sensitivity and specificity
To assess the sensitivity and specificity of the dichotomously scored AutocathFFR index per lesion.
Measured: Up to 2 months
To assess device success rate
To assess device success, measured as the ratio of completed versus initiated AutocathFFR index calculations.
Measured: Up to 2 months
To assess the Usability of the AutocathFFR
To assess the Usability of the AutocathFFR device, as evaluated using a questionnaire focusing on ease of use and intuitiveness of the system, to be completed by the user (i.e., interventional cardiologists).
Measured: Up to 2 months
Comprehensiveness of the User Manual
Comprehensiveness of the User Manual, to be rated using a questionnaire completed by the user (i.e., interventional cardiologists in the QCA Core Lab)
Measured: Up to 2 months
Device-related adverse events/malfunction
Device-related adverse events/malfunction
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start9 May 2021
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medhub Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861519
- Sponsor's protocol ID
- CLN-FFR-002
- Acronym
- AutocathFFR
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal, Single-arm Clinical Trial (Prospective Analysis of Retrospective Data) to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device in Measuring FFR From Digital Angiography Images as a Supportive Aid in the Evaluation and Assessment of Hemodynamically Significant Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04861519
- Acronym / sponsor ID
- AutocathFFR / CLN-FFR-002
- Conditions
- Stable Angina, Unstable Angina, NSTEMI
- Keywords
- coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Medhub Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Apr 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.
Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined intuitively and based on the physician eyeball. By using real-world historical data of invasive FFR, the analysis of the obtained data can ensure that the study results are expected to include invasive FFR results that are in the grey zone, when invasive FFR is used in real life and represent the real expected use of the product. Furthermore, the analysis of the data obtained in the studies with these similar devices measuring FFR obtained from angiograms was actually performed in a retrospective manner. That is, although the angiographic images and pressure wire recordings were obtained in real-time, due to the need to mark the vessel in real-time and obtain specific projections during the procedure without which the FFR cannot be calculated, the primary endpoint (sensitivity and specificity) and accuracy were determined in all studies by a post-hoc review by a similar independent QCA core laboratory. The invasive FFR data, as well as the software generated FFR data were reviewed post-hoc by a core laboratory or even at the company.
Detailed description
The proposed study is designed to compare MedHub AutocathFFR measurements obtained from angiograms for the non-invasive determination of the presence of hemodynamically significant coronary lesions. The software device will run on angiograms generated during cardiac catheterization and results will be compared to invasive FFR measurements.
The study is a prospective (analysis of retrospective data), multi-center, observational, single-arm, study.
A total of 308 cases will be enrolled in the study. The study population who represent the target population for this procedure consists of subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and for whom invasive FFR have been measured in vessels with coronary lesions. For each lesion of interest, a minimum of two 2D angiographic projections, will be obtained. Patients of both genders, all ethnicities, >18 years of age will be recruited to the study. Study cases will be sourced from numerous hospitals in the United States and Israel.
Investigators will screen cases based on the inclusion/exclusion criteria described below. General patient demographics, medical history, concomitant medications, C-arm angiography system used, FFR pressure wire used, etc., will be obtained for each study case.
Subjects with known or suspected coronary artery disease who were scheduled for clinically indicated invasive coronary angiography (ICA) and on whom invasive FFR has been measured in vessels with coronary lesions will comprise the patient population. Coronary angiography will have been performed in a routine fashion in patients with suspected coronary artery disease. When clinically indicated, invasive FFR will have been measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus.
The patient's angiographic images will be sent to an independent Quantitative Coronary Arteriography (QCA) Core Laboratory, where they will be processed using the MedHub AutocathFFR device, by independent potential users of the device (i.e., interventional cardiologists). The users will use the diagnostic angiograms and upload them to the AutocathFFR device, to generate the AutocathFFR value. The independent users will be blinded to the software device-generated FFR results and to the invasive FFR measurements. Blinding will be employed in the study because the primary endpoint, i.e., the scored FFR measurements per vessel are subject to bias by device users. Observations in patients with more than 1 study vessel will be presumed independent. The AutocathFFR will not be used for diagnostic or clinical decisions. A detailed standard operating procedure (SOP) for AutoCathFFR computation will be provided to the QCA Core Laboratory.
The AutocathFFR device automatically suggests and marks locations of suspicious narrowing and computes an FFR value for each detected area. The clinician can also select and mark manually locations with suspected narrowing for computing of FFR value. The clinical performance of AutocathFFR device depends only on the uploaded angiograms, on which the AutocathFFR results are presented alongside the viewed blood vessel. There is no need for user interaction with the system during the diagnostic angiography procedure. For example, there is no need to take specific orthogonal projection nor to designate or mark the blood vessels or segments. When the desired coronary artery is viewed on the Cath Lab monitor, the AutocathFFR measurement is automatically shown alongside the viewed vessel, if an area of narrowing is identified in the vessel. Therefore, the use of the AutocathFFR device is seamless with the angiographic imaging procedure and does not require any additional intervention by the cardiologist.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult subjects who underwent a clinically indicated invasive coronary angiography | – | Other: Collecting invasive FFR measurements.adult subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured in vessels with coronary lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- C-Arm images from adult subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured in vessels with coronary lesions.
Key inclusion criteria (6 listed)
- Age > 18 years.
- Subjects with stable angina pectoris, unstable angina pectoris or NSTEM1 and in whom invasive FFR was performed to assess a non-culprit stenosis in at least one coronary artery.
- Subject underwent a clinically indicated Invasive Coronary Angiogram (ICA).
- Subject underwent invasive FFR with IV or intracoronary Adenosine, Adenosine Triphosphate (ATP) or Papaverine used as hyperemic stimulus.
Key exclusion criteria (20 listed)
- Angiogram not obtained on an FDA cleared C-Arm angiography system.
- Invasive FFR not obtained on an FDA cleared FFR catheter tip pressure transducer (a.k.a. pressure wire).
- Vessel size less than 2 mm.
- Subject presents with an acute infarct (STEM1) OR has documented prior STEMI on same side (right/left).
- CTO in target vessel.
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 |
|---|---|---|
| Collecting invasive FFR measurements.Also: data collectionInvasive FFR measurements from the patient's hospital records will be collected. | Other | adult subjects who underwent a clinically indicated invasive coronary angiography |
Primary outcome
Evaluate the sensitivity and specificity of AutoCathFFR
Time frame: Up to 2 months
Co-primary endpoints are the sensitivity and specificity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR > 0.80 is considered "negative".
7 secondary outcomes
To assess the accuracy
Time frame: Up to 2 months
To assess the corelation bwtween invasive FFR and AutoCathFFR
Time frame: Up to 2 months
To assess the sensitivity and specificity
Time frame: Up to 2 months
To assess device success rate
Time frame: Up to 2 months
To assess the Usability of the AutocathFFR
Time frame: Up to 2 months
Comprehensiveness of the User Manual
Time frame: Up to 2 months
Device-related adverse events/malfunction
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Unstable Angina, run by Medhub Ltd. at 3 sites in Israel.
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 6 inclusion and 20 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: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the sensitivity and specificity of AutoCathFFR (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2024.