Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.

NCT04724057 | Unknown FDA Device

• 1 other identifier: CLN-FFR-002
• Study Type: interventional
• Target: 488
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

AutocathFFR; Medhub; FFR

Outcome Measures

Primary Outcomes (1)

• 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".

  Immediate after procedure

Interventions

AutocathFFR DEVICE

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medhub Ltd.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-01