Status:
UNKNOWN
Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.
Lead Sponsor:
Medhub Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 Aut...
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 sub...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT04724057
Start Date
June 1 2021
End Date
August 1 2021
Last Update
April 20 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.