Coronary Artery DiseaseNCT04724057
Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.
A study testing AutocathFFR in people with Coronary Artery Disease, run by Medhub Ltd..
Trial summary
Patients with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure will be enrolled in the study. The angiographic images will be processed by the Medhub Autocath FFR device to generate the Autocath FFR measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- AutocathFFR
- Type of treatment
- Medical device
- How many people
- 488 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Aug 2021
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years.
- Subjects with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure.
- Subject is planned to undergo an invasive FFR with IV or intracoronary Adenosine, Adenosine Triphosphate (ATP) or Papaverine used as hyperemic stimulus*.
- Not mandatory for lesions in the LAD
Who cannot join
- Vessel size less than 2 mm.
- CTO in target vessel.
- Prior CABG, heart transplant or valve surgery, prior TAVI/TAVR or severe left sided valvular disease.
- TIMI Grade 2 or lower.
- Target lesion involves Left Main (stenosis >50%).
- Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
About this study
Patients with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure will be enrolled in the study. The angiographic images will be processed by the Medhub Autocath FFR device to generate the Autocath FFR measurement. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR (using a coronary pressure wire and hyperemic stimulus) is not mandatory for lesions in the LAD, although it is at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Artery (RCA) and Left Circumflex Coronary (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. In these cases, the Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available.
The dichotomously scored MedHub Autocath FFR per vessel will be compared to the invasive FFR, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The sensitivity and specificity of the MedHub Autocath FFR will be calculated.
Read the detailed description
The proposed study is designed to assess performance and safety data for the MedHub Autocath FFR device.
The study is a prospective, multi-center, single-arm, post-marketing study. A total of 488 subjects will be enrolled in the study. The study population who represent the target population for this procedure consists of subjects with known or suspected coronary artery disease (CAD) who are scheduled to undergo a coronary angiography procedure and on whom invasive FFR will be measured in vessels with meaningful coronary lesions. Patients of both genders, all ethnicities, >18 years of age will be recruited to the study. Study subjects will be enrolled from numerous hospitals in Israel.
Investigators will screen subjects 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 study subject.
Subjects with known or suspected coronary artery disease who are scheduled for clinically indicated invasive coronary angiography will comprise the patient population. Coronary angiography will be performed in a routine fashion in patients with suspected coronary artery disease. The collected diagnostic angiography images will be processed using the Medhub Autocath FFR device to generate the Autocath FFR. Based on operator's discretion, the location of the stenosis and when clinically indicated, invasive FFR will be measured using a coronary pressure wire and hyperemic stimulus.
The patient's angiographic images will be processed using the MedHub Autocath FFR device. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR will not be mandatory for lesions in the LAD, and it will be at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Anterior (RCA) and Left Circumflex (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. That is, in these cases the MedHub Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available.
The dichotomously scored MedHub Autocath FFR per vessel will be compared to the invasive FFR, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The sensitivity and specificity of the MedHub Autocath FFR will be calculated. Furthermore, the MedHub Autocath FFR accuracy, positive predictive value and negative predictive value per vessel and per lesion will be determined.
Usability of the MedHub Autocath FFR device will also be assessed including User Manual comprehension and usability of the device in the hands of the users (i.e., interventional cardiologists).
Details on the timing of all study procedures are given in the Time and Events Schedule in Attachment B of the Protocol. The anticipated enrollment period is approximately 6 months and therefore, the complete duration of the study is expected to last 8-9 months, during which time 488 patients will be enrolled at 3-5 sites.
- Conditions
- Coronary Artery Disease
- Being tested
- AutocathFFR
- Keywords
- AutocathFFR, Medhub, FFR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutocathFFRDevice
The MedHub Autocath FFR device is a software only medical device. The FFR is computed from several standard DICOM format 2D angiography images retrieved from the C-arm imaging system, which display the structure of the vessels. The MedHub AutocathFFR device software analyzes these images and automatically (without the need for user selection or markings) and computes and displays the FFR on the viewed blood vessel.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
Co-primary endpoints are the sensitivity and specificity of the dichotomously scored MedHub Autocath FFR per vessel compared to invasive FFR, where an FFR ≤ 0.80 is scored "positive", while an FFR > 0.8 is considered "negative".
Measured: Immediate after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medhub Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724057
- Sponsor's protocol ID
- CLN-FFR-002
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.
- ClinicalTrials.gov ID
- NCT04724057
- Acronym / sponsor ID
- CLN-FFR-002
- Conditions
- Coronary Artery Disease
- Keywords
- AutocathFFR, Medhub, FFR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Medhub Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 26 Jan 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.
Patients with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure will be enrolled in the study. The angiographic images will be processed by the Medhub Autocath FFR device to generate the Autocath FFR measurement. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR (using a coronary pressure wire and hyperemic stimulus) is not mandatory for lesions in the LAD, although it is at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Artery (RCA) and Left Circumflex Coronary (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. In these cases, the Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available.
The dichotomously scored MedHub Autocath FFR per vessel will be compared to the invasive FFR, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The sensitivity and specificity of the MedHub Autocath FFR will be calculated.
Detailed description
The proposed study is designed to assess performance and safety data for the MedHub Autocath FFR device.
The study is a prospective, multi-center, single-arm, post-marketing study. A total of 488 subjects will be enrolled in the study. The study population who represent the target population for this procedure consists of subjects with known or suspected coronary artery disease (CAD) who are scheduled to undergo a coronary angiography procedure and on whom invasive FFR will be measured in vessels with meaningful coronary lesions. Patients of both genders, all ethnicities, >18 years of age will be recruited to the study. Study subjects will be enrolled from numerous hospitals in Israel.
Investigators will screen subjects 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 study subject.
Subjects with known or suspected coronary artery disease who are scheduled for clinically indicated invasive coronary angiography will comprise the patient population. Coronary angiography will be performed in a routine fashion in patients with suspected coronary artery disease. The collected diagnostic angiography images will be processed using the Medhub Autocath FFR device to generate the Autocath FFR. Based on operator's discretion, the location of the stenosis and when clinically indicated, invasive FFR will be measured using a coronary pressure wire and hyperemic stimulus.
The patient's angiographic images will be processed using the MedHub Autocath FFR device. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR will not be mandatory for lesions in the LAD, and it will be at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Anterior (RCA) and Left Circumflex (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. That is, in these cases the MedHub Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available.
The dichotomously scored MedHub Autocath FFR per vessel will be compared to the invasive FFR, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The sensitivity and specificity of the MedHub Autocath FFR will be calculated. Furthermore, the MedHub Autocath FFR accuracy, positive predictive value and negative predictive value per vessel and per lesion will be determined.
Usability of the MedHub Autocath FFR device will also be assessed including User Manual comprehension and usability of the device in the hands of the users (i.e., interventional cardiologists).
Details on the timing of all study procedures are given in the Time and Events Schedule in Attachment B of the Protocol. The anticipated enrollment period is approximately 6 months and therefore, the complete duration of the study is expected to last 8-9 months, during which time 488 patients will be enrolled at 3-5 sites.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years.
- Subjects with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure.
- Subject is planned to undergo an invasive FFR with IV or intracoronary Adenosine, Adenosine Triphosphate (ATP) or Papaverine used as hyperemic stimulus*.
Key exclusion criteria (6 listed)
- Vessel size less than 2 mm.
- CTO in target vessel.
- Prior CABG, heart transplant or valve surgery, prior TAVI/TAVR or severe left sided valvular disease.
- TIMI Grade 2 or lower.
- Target lesion involves Left Main (stenosis >50%).
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 |
|---|---|---|
| AutocathFFRThe MedHub Autocath FFR device is a software only medical device. The FFR is computed from several standard DICOM format 2D angiography images retrieved from the C-arm imaging system, which display the structure of the vessels. The MedHub AutocathFFR device software analyzes these images and automatically (without the need for user selection or markings) and computes and displays the FFR on the viewed blood vessel. | Device | – |
Primary outcome
Sensitivity and specificity
Time frame: Immediate after procedure
Co-primary endpoints are the sensitivity and specificity of the dichotomously scored MedHub Autocath FFR per vessel compared to invasive FFR, where an FFR ≤ 0.80 is scored "positive", while an FFR > 0.8 is considered "negative".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing AutocathFFR in people with Coronary Artery Disease, run by Medhub Ltd..
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 4 inclusion and 6 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity and specificity (time frame: Immediate after procedure). 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 20 Apr 2021.