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Physio-Anatomy Clinical Data Collection Study

NCT05312164 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-03-20

No results posted yet for this study

Summary

This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

Conditions

  • Coronary Stenosis

Interventions

DEVICE

HF-OCT Imaging

Subjects undergo HF-OCT imaging of stenosed coronary arteries

DEVICE

FFR Pressure Wire

Subjects undergo FFR physiology assessment of stenosed coronary arteries

DEVICE

Angiography

Subjects undergo angiography imaging of stenosed coronary arteries

Sponsors & Collaborators

  • Gentuity, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05312164 on ClinicalTrials.gov