Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

NCT07676097 | Not Yet Recruiting

• 1 other identifier: CSP-001
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 9

Brief Summary

The aim of this study is to establish the diagnostic performance of the AngioAI+ System (AngioInsight, Inc, USA) for estimating:

1. 1.Fractional flow reserve (FFR) and
2. 2.Detection of coronary microvascular disease (CMD)

Conditions

Non-obstructive Coronary Disease; Acute or Chronic Coronary Artery Disease

Keywords

fractional flow reserve; coronary microvascular disease

Outcome Measures

Primary Outcomes (2)

• To establish the diagnostic performance of the AngioAI+ System

  1\. Per-vessel diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ FFR for identifying flow-limiting lesions, using measured FFR as the reference standard.

  June 2026 to December 2027

• To establish the diagnostic performance of AngioAI+ System

  Description: 2. Diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ for detecting CMD in patients with non-obstructive CAD using invasive coronary flow reserve (CFR) derived from continuous thermodilution as reference.

  June 2026 to December 2027

Study Arms (2)

Cohort 1

Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment

Procedure: Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment.

Cohort 2

Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment

Procedure: Microvascular assessment

Interventions

Microvascular assessment PROCEDURE

Cohort 2: Patients with non-obstructive (\<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.

Cohort 2

Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment. PROCEDURE

Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.

Cohort 1

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

Patients with acute or chronic coronary artery disease

You may qualify if:

• Patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated coronary physiologic assessment. In patients with acute coronary syndromes, the physiological evaluation will be restricted to non-culprit vessels.
• Patients with intermediate CAD (30-90% visual stenosis) with clinically indicated FFR assessment.
• Patients with NOCAD (\<30% visual stenosis) with clinically indicated microvascular assessment.

You may not qualify if:

• Patients presenting with ST-elevation
• Prior myocardial infarction in the target vessel
• Stent implantation in the target vessel within the last 12 months
• Previous coronary artery bypass grafting surgery (CABG)
• Previous heart valve surgery
• Previous heart transplantation
• Moderate-to-severe valvular disease
• Left ventricular ejection fraction (EF) ≤45%
• Hemodynamic instability or cardiogenic shock
• Left main stenosis≥50%
• Chronic total occlusion in the target vessel
• CTO in a non-target vessel
• Less than thrombolysis in myocardial infarction (TIMI) 3 flow in the target vessel
• Target vessel receiving collaterals
• Inadequate coronary angiographic images

Sponsors & Collaborators

• AngioInsight: lead

Study Sites (9)

Palo Alto Veterans Administration Hospital

Palo Alto, California, 94304, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Minneapolis Heart

Minneapolis, Minnesota, 55407, United States

Location

Valley Health System

Paramus, New Jersey, 07652, United States

Location

New York University

New York, New York, 10016, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Carlos Collet, MD, PhD

  Cardiovascular Research Foundation; OLV Aalst

  PRINCIPAL INVESTIGATOR

• Todd C Villines, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sr. VP Regulatory Affairs - AngioInsight

CONTACT

16122675004; gzaeska@angioinsight.com

Project Manager - Cardiovascular Research Foundation

CONTACT

jungarten@crf.org

Study Design

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

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

US (9)