NCT05312164

Physio-Anatomy Clinical Data Collection Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Gentuity, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include: * A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking. * Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters. * Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.

Conditions

• Coronary Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-14
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-04-05
• Last updated: 2025-03-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study