Status:
COMPLETED
Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device
Lead Sponsor:
Medhub Ltd.
Conditions:
Stable Angina
Unstable Angina
Eligibility:
All Genders
18+ years
Brief 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 invas...
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. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT04861519
Start Date
May 9 2021
End Date
December 31 2021
Last Update
March 26 2024
Active Locations (3)
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1
Hillel Yaffe Medical Center
Hadera, Central District, Israel
2
Rambam Medical Center
Haifa, North, Israel
3
Soroka Medical Center
Beersheba, South, Israel