Status:
COMPLETED
The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
Lead Sponsor:
Keya Medical
Collaborating Sponsors:
Medical University of South Carolina
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Brief Summary
DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT ...
Detailed Description
Coronary artery disease (CAD) is the most common type of heart disease, and it is the leading cause of death worldwide in both men and women. CAD happens when the coronary arteries become hardened and...
Eligibility Criteria
Inclusion
- Patients' age ≥18 years;
- Has coronary CTA images acquired by ≥64 multidetector row CT scanner, no earlier than 2016 and within 60 days of the ICA-FFR procedure;
- Coronary CTA image shows at least one vessel segment (≥2mm diameter) with a diameter stenosis of 30%-90%;
Exclusion
- Patients with any of the following conditions at the time of CTA imaging:
- Acute myocardial infarction;
- Unstable angina;
- Pulmonary edema;
- Heart function classification level III and IV (NYHA heart function classification);
- Implantable cardioverter defibrillator (ICD);
- Prior percutaneous coronary intervention (PCI) or pacemaker surgery;
- Prior coronary artery bypass grafting (CABG) surgery;
- Prior heart valve replacement;
- Prior history of complex congenital heart disease;
- Prior history of cardiomyopathy;
- BMI \>35;
- Coronary total occlusion.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT04828590
Start Date
August 10 2020
End Date
December 31 2021
Last Update
April 22 2022
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Holy Cross Health
Fort Lauderdale, Florida, United States, 33308
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
3
Oregon Health & Science University
Portland, Oregon, United States, 97239
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29407