Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

NCT01233518 | Completed Results DMC

• 1 other identifier: CP-901-001
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

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 coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

Conditions

Coronary Artery Disease

Keywords

CCTA Coronary Artery Disease CAD

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone

  Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.

  1 day

Secondary Outcomes (1)

• Diagnostic Performance of CCTA Plus FFRCT at the Subject Level

  1 day

Study Arms (1)

Single arm study

OTHER

Patients will receive cCTA, ICA, FFR, and cFFR per protocol.

Device: FFR

Interventions

FFR DEVICE

Fractional flow reserve measured during cardiac catheterization

Single arm study

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HeartFlow, Inc.: lead
• Baim Institute for Clinical Research: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• Minneapolis Heart Institute Foundation: collaborator

Study Sites (1)

Spring Hill Hospital

Mobile, Alabama, 36608, United States

Location

Related Publications (3)

• Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GB, Mauri L, Schwartz RS, Shaw LJ. Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study. J Cardiovasc Comput Tomogr. 2011 Sep-Oct;5(5):301-9. doi: 10.1016/j.jcct.2011.08.003. Epub 2011 Aug 7.

  PMID: 21930103 BACKGROUND

• Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.

  PMID: 22922562 RESULT

• Park HB, Heo R, O Hartaigh B, Cho I, Gransar H, Nakazato R, Leipsic J, Mancini GBJ, Koo BK, Otake H, Budoff MJ, Berman DS, Erglis A, Chang HJ, Min JK. Atherosclerotic plaque characteristics by CT angiography identify coronary lesions that cause ischemia: a direct comparison to fractional flow reserve. JACC Cardiovasc Imaging. 2015 Jan;8(1):1-10. doi: 10.1016/j.jcmg.2014.11.002.

  PMID: 25592691 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Whitney Huey
• Organization: Heartflow, Inc.

whuey@heartflow.com

650.257.6697

Study Officials

• James K Min, MD, FACC

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: November 3, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 9, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)