Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device

NCT04861519 | Completed

• 1 other identifier: CLN-FFR-002
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Stable Angina; Unstable Angina; NSTEMI

Keywords

coronary angiography

Outcome Measures

Primary Outcomes (1)

• 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".

  Up to 2 months

Secondary Outcomes (7)

• To assess the accuracy

  Up to 2 months

• To assess the corelation bwtween invasive FFR and AutoCathFFR

  Up to 2 months

• To assess the sensitivity and specificity

  Up to 2 months

• To assess device success rate

  Up to 2 months

• To assess the Usability of the AutocathFFR

  Up to 2 months

Study Arms (1)

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.

Other: Collecting invasive FFR measurements.

Interventions

Collecting invasive FFR measurements. OTHER

Invasive FFR measurements from the patient's hospital records will be collected.

Also known as: data collection

adult subjects who underwent a clinically indicated invasive coronary angiography

Eligibility Criteria

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Medhub Ltd.: lead

Study Sites (3)

Hillel Yaffe Medical Center

Hadera, Central District, Israel

Location

Rambam Medical Center

Haifa, North, Israel

Location

Soroka Medical Center

Beersheba, South, Israel

Location

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 27, 2021
• Study Start: May 9, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IL (3)