Status:
COMPLETED
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Lead Sponsor:
HeartFlow, Inc.
Collaborating Sponsors:
Baim Institute for Clinical Research
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by...
Detailed Description
285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology)...
Eligibility Criteria
Inclusion
- Age \>18 years
- Patients providing written informed consent
- Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
- Has undergone \>64 multidetector row CCTA within 60 days prior to ICA
- No cardiac interventional therapy between the CCTA and ICA
Exclusion
- Prior coronary artery bypass graft (CABG) surgery
- Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
- Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD
- Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- Recent prior myocardial infarction within 40 days of ICA
- Known complex congenital heart disease
- Prior pacemaker or internal defibrillator lead implantation
- Prosthetic heart valve
- Significant arrhythmia or tachycardia
- Impaired chronic renal function (serum creatinine \>1.5 mg/dl
- Patients with known anaphylactic allergy to iodinated contrast
- Pregnancy or unknown pregnancy status
- Body mass index \>35
- Patient requires an emergent procedure
- Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
- Any active, serious, life-threatening disease with a life expectancy of less than 2 months
- Inability to comply with study procedures
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01233518
Start Date
October 1 2010
End Date
November 1 2011
Last Update
February 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Spring Hill Hospital
Mobile, Alabama, United States, 36608