The DISCOVER INOCA Prospective Multi-center Registry

Last updated: December 16, 2025
Sponsor: Yale University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Occlusions

Heart Disease

Myocardial Ischemia

Treatment

Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Clinical Study ID

NCT05288361
YSI-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Suspected ischemic heart disease and is referred to undergo clinically indicatedinvasive coronary angiography

  • No obstructive coronary artery disease (CAD) as defined by operator visualassessment with (1) angiographically normal coronary arteries OR (2) non-obstructiveCAD with angiographic stenosis < 50%, or greater than or equal to 50 but < 70% withFFR greater than or equal to 0.81 or RFR greater than or equal to 0.90

  • Willing to comply with specified follow-up evaluations. The participant or legallyauthorized representative has been informed of the nature of the study, agrees toits provisions, and has been provided written informed consent approved by theappropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion

Exclusion Criteria:

  • Pregnant or nursing

  • Any myocardial infarction at index presentation or within 90 days prior toenrollment, defined as any electrocardiogram diagnostic for myocardial infarction ORelevation in serum troponin greater than the upper limit of the site-definedreference range

  • Known left ventricular ejection fraction < 50% or cardiogenic shock requiringpressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, leftventricular assist device, other temporary cardiac support blood pump)

  • Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation) or dialysisat the time of screening

  • Prior percutaneous coronary intervention

  • Planned percutaneous coronary intervention (PCI)

  • Prior coronary artery bypass graft surgery

  • Prior ST-elevation myocardial infarction

  • History of hypertrophic cardiomyopathy

  • History of infiltrative heart disease (e.g., cardiac amyloidosis)

  • New York Heart Association Class IV congestive heart failure

  • Severe mitral regurgitation

  • Severe aortic stenosis

  • Severe pulmonary hypertension (Mean pulmonary artery pressure greater than or equalto 35mmHg or echocardiographic right ventricular systolic pressure greater than orequal to 60mmHg)

  • Known history of unrepaired or repaired congenital heart disease

  • Past or pending heart transplant, or on the waiting list for organ transplant

  • Known other medical illness or known history of substance abuse that may causenon-compliance with the protocol, or is associated with a life expectancy of lessthan 1 year

  • Current or planned participation in a study of an investigational therapy

  • Angiographic stenosis in any major epicardial vessel ≥ 70% by visual estimate

  • Angiographic stenosis in any major epicardial vessel greater than or equal to 50%and < 70% by visual estimate with FFR less than or equal to 0.80 or RFR less than orequal to 0.89

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Phase:
Study Start date:
September 14, 2022
Estimated Completion Date:
December 31, 2032

Study Description

This is a prospective, multicenter, registry of stable patients with ischemia and no obstructive coronary artery disease (INOCA) evaluated by coronary angiography, intravascular imaging, and physiologic measurements obtained on the Coroventis Coroflow Cardiovascular System.

The Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire (Abbott, Abbott Park, IL) are a device combination consisting of a physiology wire with wireless transmitter (Wi-Box), CoroHub Receiver, and CoroFlow Software. The PressureWire™ X guidewire is a hydrophilic-coated wire with pressure and temperature sensors that is capable of measuring physiologic indices including fractional flow reserve (FFR), resting full cycle ratio (RFR), coronary flow reserve (CFR), and the index of microcirculatory resistance (IMR). The guidewire wirelessly transmits pressure and temperature data via the Wi-Box to the CoroHub Receiver and CoroFlow Software, which is a software interface designed to display pressure measurements, thermodilution curves, and physiologic indices. This registry will enroll 500 subjects at up to 10 sites in the United States that use the Abbott Coroventis Coroflow Cardiovascular System.

The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes. Specific goals include:

  • Describe the prevalence of the following INOCA phenotypes: coronary microvascular dysfunction (CMD), vasospastic angina, mixed CMD/vasospastic angina, other disorders of coronary physiology, and non-cardiac chest pain;

  • Characterize the burden of epicardial coronary artery atherosclerosis and myocardial bridging (MB) by angiography and intracoronary imaging (intravascular ultrasound or optical coherence tomography) in patients with INOCA;

  • Characterize the natural history and outcomes of patients with INOCA and determine variables associated with major adverse cardiovascular events

Connect with a study center

  • UCLA Health

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford Hospital

    Stanford, California 94305
    United States

    Site Not Available

  • UCLA Health

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Stanford Hospital

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Site Not Available

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Northeast Georgia Medical Center

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • New York Presbyterian-Brooklyn Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10010
    United States

    Site Not Available

  • New York Presbyterian-Brooklyn Methodist Hospital

    Brooklyn 5110302, New York 5128638 11215
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10010
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

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