Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve

NCT06844942 | Recruiting

• 1 other identifier: VISION-FFR
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis; Tomography, Optical Coherence; 3D-angio-based FFR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Major adverse cardiovascular events

  36 months

Study Arms (1)

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

Interventions

vessel Fractional Flow Reserve DIAGNOSTIC_TEST

Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.

Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis.

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

1st Department and Clinic of Cardiology, Medical University of Warsaw

Warsaw, Mazowieckie Voivodenship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mariusz Tomaniak, MD, PhD, Assoc. Prof.

CONTACT

0048225991958; mariusz.tomaniak@wum.edu.pl

Piotr Baruś, MD

CONTACT

piotr.barus@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mariusz Tomaniak, MD, PhD, Assoc. Prof.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: September 20, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)