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NCT05312164 · ClinicalTrials.gov registry record
Physio-Anatomy Clinical Data Collection Study
A clinical trial of Coronary Stenosis, sponsored by Gentuity.
- Recruiting
- Registry status
- 150
- Enrollment target
- 6
- Study locations
NCT05312164: Recruiting study of Coronary Stenosis, sponsored by Gentuity.
NCT05312164 is a study of Coronary Stenosis that is actively recruiting participants, run by Gentuity. The registered enrollment target is 150 participants, below the 1,332-participant average among 5 other Coronary Stenosis trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05312164, a study of Coronary Stenosis, is actively recruiting participants, sponsored by Gentuity.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback.
Conditions Studied
Interventions
- DEVICE HF-OCT Imaging
- DEVICE FFR Pressure Wire
- DEVICE Angiography
Study Locations (6)
California
- Veteran's Administration Palo Alto - Palo Alto
Florida
- Tampa General Hospital - Tampa
Georgia
- Atlanta VA Medical Center - Decatur
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Minnesota
- Minneapolis VA Medical Center - Minneapolis
Ohio
- The Christ Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2025-12-31 |
What NCT05312164 shows while recruiting
NCT05312164 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,332-participant average among 5 other Coronary Stenosis trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Coronary Stenosis appearing as the primary indexed condition, and to 3 interventions - of which HF-OCT Imaging is the first listed.
NCT05312164 lists 6 locations in 6 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT05312164 about?
NCT05312164 is a clinical study titled "Physio-Anatomy Clinical Data Collection Study". 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.
What is the current status of trial NCT05312164?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2022-03-14. Estimated completion is 2025-12-31.
What conditions does trial NCT05312164 study?
This clinical trial studies the following conditions: Coronary Stenosis.
What interventions are being tested in trial NCT05312164?
The interventions under investigation include: HF-OCT Imaging (DEVICE), FFR Pressure Wire (DEVICE), Angiography (DEVICE).
Who is sponsoring clinical trial NCT05312164?
This trial is sponsored by Gentuity, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05312164 being conducted?
This trial has 6 study locations across California, Florida, Georgia, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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