ELUCIDATE FFRct Study

NCT06018194 | Recruiting FDA Device

• 1 other identifier: 3-ST-03-03
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR). Researchers will compare the Elucid plaque-based FFRct analysis to invasively measured FFR in patients who have previously undergone CCTA and invasively assessed FFR.

Conditions

Coronary Artery Disease

Keywords

coronary computed tomographic angiography; coronary CTA; cardiac CT; fractional flow reserve; plaque

Outcome Measures

Primary Outcomes (2)

• Sensitivity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80

  Per-vessel

  1 day

• Specificity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80

  Per-vessel

  1 day

Secondary Outcomes (10)

• Sensitivity of FFRct for detecting invasive FFR ≤ 0.80

  1 day

• Specificity of FFRct for detecting invasive FFR ≤ 0.80

  1 day

• Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80

  1 day

• Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80

  1 day

• Accuracy of FFRct for detecting invasive FFR ≤ 0.80

  1 day

Study Arms (2)

Low FFR

Invasive FFR \<= 0.80

Device: ElucidVivo

High FFR

Invasive FFR \> 0.80

Device: ElucidVivo

Interventions

ElucidVivo DEVICE

Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)

High FFR; Low FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \>=18 years with at least one 30-90% stenosis on CCTA (\>64- detector row) performed within 60 days of undergoing invasive FFR.

You may qualify if:

• \- Adults \>=18 years with at least one 30-90% stenosis on CCTA (\>64- detector row) performed within 60 days of undergoing invasive FFR.

You may not qualify if:

• History of coronary revascularization with coronary artery bypass graft (CABG) surgery and/or percutaneous coronary intervention (PCI) (stent or balloon angioplasty) prior to CCTA and invasive FFR.
• History of myocardial infarction prior to CCTA and invasive FFR.
• Known complex congenital heart disease.
• Existing pacemaker or internal defibrillator lead implantation(s).
• Existing prosthetic heart valve.
• Absence of CCTA Digital Imaging and Communications in Medicine (DICOM) data for analysis.
• Absence of invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location.
• Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFRct.
• Absence of study date for CCTA or invasive FFR.
• Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization procedure between CCTA and invasive FFR.
• Non-diagnostic CCTA or invasive FFR. Studies where the results of the study were deemed non-diagnostic for clinical decision-making will be excluded.
• CCTA or invasive FFR studies performed prior to 1 January 2016.

Sponsors & Collaborators

• Elucid Bioimaging Inc.: lead
• Lundquist Institute at Harbor-UCLA Medical Center: collaborator

Study Sites (9)

Cardiovascular Medical Group of Southern California

Beverly Hills, California, 90210, United States

NOT YET RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

NOT YET RECRUITING

Parkview Health

Fort Wayne, Indiana, 46845, United States

NOT YET RECRUITING

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211, United States

RECRUITING

Valley Health System

Ridgewood, New Jersey, 07450, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Centennial Heart

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Ascension Medical Group

Nashville, Tennessee, 37205, United States

NOT YET RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (9)

• Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e4-e17. doi: 10.1161/CIR.0000000000001039. Epub 2021 Dec 9.

  PMID: 34882436 BACKGROUND

• Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, Diercks DB, Gentile F, Greenwood JP, Hess EP, Hollenberg SM, Jaber WA, Jneid H, Joglar JA, Morrow DA, O'Connor RE, Ross MA, Shaw LJ. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Nov 30;144(22):e368-e454. doi: 10.1161/CIR.0000000000001029. Epub 2021 Oct 28.

  PMID: 34709879 BACKGROUND

• Tesche C, De Cecco CN, Caruso D, Baumann S, Renker M, Mangold S, Dyer KT, Varga-Szemes A, Baquet M, Jochheim D, Ebersberger U, Bayer RR 2nd, Hoffmann E, Steinberg DH, Schoepf UJ. Coronary CT angiography derived morphological and functional quantitative plaque markers correlated with invasive fractional flow reserve for detecting hemodynamically significant stenosis. J Cardiovasc Comput Tomogr. 2016 May-Jun;10(3):199-206. doi: 10.1016/j.jcct.2016.03.002. Epub 2016 Mar 10.

  PMID: 26993434 BACKGROUND

• Ahmadi A, Stone GW, Leipsic J, Serruys PW, Shaw L, Hecht H, Wong G, Norgaard BL, O'Gara PT, Chandrashekhar Y, Narula J. Association of Coronary Stenosis and Plaque Morphology With Fractional Flow Reserve and Outcomes. JAMA Cardiol. 2016 Jun 1;1(3):350-7. doi: 10.1001/jamacardio.2016.0263.

  PMID: 27438119 BACKGROUND

• Diaz-Zamudio M, Dey D, Schuhbaeck A, Nakazato R, Gransar H, Slomka PJ, Narula J, Berman DS, Achenbach S, Min JK, Doh JH, Koo BK. Automated Quantitative Plaque Burden from Coronary CT Angiography Noninvasively Predicts Hemodynamic Significance by using Fractional Flow Reserve in Intermediate Coronary Lesions. Radiology. 2015 Aug;276(2):408-15. doi: 10.1148/radiol.2015141648. Epub 2015 Apr 17.

  PMID: 25897475 BACKGROUND

• Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.

  PMID: 33529657 BACKGROUND

• Stuijfzand WJ, van Rosendael AR, Lin FY, Chang HJ, van den Hoogen IJ, Gianni U, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Thompson R, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Al-Mallah MH, Lu Y, Berman DS, Narula J, Min JK, Bax JJ, Shaw LJ; CREDENCE Investigators. Stress Myocardial Perfusion Imaging vs Coronary Computed Tomographic Angiography for Diagnosis of Invasive Vessel-Specific Coronary Physiology: Predictive Modeling Results From the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) Trial. JAMA Cardiol. 2020 Dec 1;5(12):1338-1348. doi: 10.1001/jamacardio.2020.3409.

  PMID: 32822476 BACKGROUND

• Lin A, van Diemen PA, Motwani M, McElhinney P, Otaki Y, Han D, Kwan A, Tzolos E, Klein E, Kuronuma K, Grodecki K, Shou B, Rios R, Manral N, Cadet S, Danad I, Driessen RS, Berman DS, Norgaard BL, Slomka PJ, Knaapen P, Dey D. Machine Learning From Quantitative Coronary Computed Tomography Angiography Predicts Fractional Flow Reserve-Defined Ischemia and Impaired Myocardial Blood Flow. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014369. doi: 10.1161/CIRCIMAGING.122.014369. Epub 2022 Oct 13.

  PMID: 36252116 BACKGROUND

• Buckler AJ, Sakamoto A, Pierre SS, Virmani R, Budoff MJ. Virtual pathology: Reaching higher standards for noninvasive CTA tissue characterization capability by using histology as a truth standard. Eur J Radiol. 2023 Feb;159:110686. doi: 10.1016/j.ejrad.2022.110686. Epub 2022 Dec 31.

  PMID: 36603478 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ziad Ali, MD

  Catholic Health - St. Francis Hospital

  PRINCIPAL INVESTIGATOR

• Todd C Villines, MD

  Elucid Bioimaging Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd C Villines, MD

CONTACT

978-468-0508; todd.villines@elucid.com

John Aluru, MBBS

CONTACT

978-468-0508; john.aluru@elucid.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 30, 2023
• Study Start: September 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)