Physio-Anatomy Clinical Data Collection Study

ConditionCoronary Stenosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorGentuity, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients >18 years of age.

Patients provide written informed consent.

Clinical presentation consistent with suspected coronary disease.

Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.

Disqualifiers

Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.

Contraindication for FFR examination or administration of vasodilators.

Bacteremia or sepsis.

Major coagulation system abnormalities.

Trial population

Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath lab.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Candidates for PCI3 interventions

Trial outcomes

Primary outcomes

Collection of angiography images, HF-OCT images, and FFR pressure wire data

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.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gentuity, LLC

Lead sponsor

Source ClinicalTrials.gov

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