Physio-Anatomy Clinical Data Collection Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Gentuity, LLC
Study ID
NCT05312164
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HF-OCT Imaging — DEVICE
    Subjects undergo HF-OCT imaging of stenosed coronary arteries
  • FFR Pressure Wire — DEVICE
    Subjects undergo FFR physiology assessment of stenosed coronary arteries
  • Angiography — DEVICE
    Subjects undergo angiography imaging of stenosed coronary arteries

Study Details

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.

Key Dates

Start date
Mar 14, 2022
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Candidates for PCI
    Patients undergoing diagnostic cardiac catheterization/PCI.

Primary Outcome Measure

Collection of angiography images, HF-OCT images, and FFR pressure wire data [ Time Frame: 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Veteran's Administration Palo AltoPalo AltoCalifornia94304
William Fearon, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Thanh Tran
[email protected]
813-844-8544
Hiram Bezerra, MD (PRINCIPAL_INVESTIGATOR)
Atlanta VA Medical CenterDecaturGeorgia30033
Gautam Kumar, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Eric A Osborn, MD, PhD (PRINCIPAL_INVESTIGATOR)
Minneapolis VA Medical CenterMinneapolisMinnesota55417
Alok Sharma, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Jarrod Frizzell, MD (PRINCIPAL_INVESTIGATOR)

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Veteran's Administration Palo Alto· Palo Alto, CATampa General Hospital· Tampa, FLAtlanta VA Medical Center· Decatur, GABeth Israel Deaconess Medical Center· Boston, MAMinneapolis VA Medical Center· Minneapolis, MNThe Christ Hospital· Cincinnati, OH

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