The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
Completed
Conditions studied: Coronary Artery Disease, Myocardial Ischemia
In brief
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 angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.
Key facts
- Study ID
- NCT04828590
- Run by
- Keya Medical
- People needed
- 302
- Starts
- 2020-08-10
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2022-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%;
You may not qualify if…
- 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.
Where it is running
- Holy Cross Health — Fort Lauderdale, Florida, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Medical University Innsbruck — Innsbruck, Austria
- Institute of Arnualt Tzanck — Nice, Saint-Laurent-du-Var, France
- University of Ferrara — Ferrara, Italy
- University of Milan — Milan, Italy
- National Institute of Cardiology — Warsaw, Poland
Full record on ClinicalTrials.gov
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