Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve (VISION-FFR)

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Stenosis; Tomography, Optical Coherence; 3D-angio-based FFR
• Intervention / Treatment: Diagnostic test: vessel Fractional Flow Reserve

Detailed Description

This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (OCT) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

The additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vFFR results and morphometric indices of intermediate coronary stenosis.

We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vFFR and the morphometric parameters associated with coronary stenosis.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Piotr Baruś, MD; Email: piotr.barus@wum.edu.pl
• Study Contact Backup: Name: Mariusz Tomaniak, MD, PhD, Assoc. Prof.; Phone Number: 0048225991958; Email: mariusz.tomaniak@wum.edu.pl

Study Locations

• Poland
  • Mazowieckie Voivodenship
    • Warsaw, Mazowieckie Voivodenship, Poland, 02-097
      • Recruiting
      • 1st Department and Clinic of Cardiology, Medical University of Warsaw
      • Contact: Mariusz Tomaniak, MD, PhD, Assoc. Prof.; Phone Number: +48 22 599-19-58; Email: mariusz.tomaniak@wum.edu.pl
      • Contact: Mariusz Tomaniak, MD, PhD, Assoc. Prof.
      • Contact: Piotr Baruś, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.

Description

Inclusion Criteria:

• 18 years or older
• Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
• Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent

Exclusion Criteria:

• Acute coronary syndrome
• Proximal left main lesion
• Ostial right coronary artery lesion
• Bypass of the assessed vessel
• Contraindications for adenosine administration
• Hemodynamic instability
• Heart insufficiency in New York Heart Association (NYHA) class IV scale
• Acute renal insufficiency
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis.; Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.	Diagnostic test: vessel Fractional Flow Reserve; Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis	Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis	0 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	Major adverse cardiovascular events	36 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: VISION-FFR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No