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NCT04533503 Clinical Trial

Vis-Rx Post-Market Evaluation

Coronary Artery Disease Clinical Trial

— Vis-Rx PME  

Official title:
Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04533503
Other study ID # 003175
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 22, 2021
Est. completion date January 25, 2023

Study information
Verified date February 2024
Source Gentuity, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.

Description:

Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date January 25, 2023
Est. primary completion date January 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - Willing and able to provide written informed consent to participate - Transluminal interventional procedure for their coronary arteries General Exclusion Criteria: - Bacteremia or sepsis - Major coagulation system abnormalities - Severe hemodynamic instability or shock - Acute renal failure - Disqualified for Coronary Artery Bypass Graft (CABG) surgery - Disqualified for PCI procedure - Currently enrolled in another study to evaluate an investigational device or medication Lesion-Specific Exclusion Criteria: - Total occlusion - Coronary artery spasm - Large thrombus (visible under angiography) - Any target vessel which has undergone a bypass procedure

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Baptist Health Lexington Lexington Kentucky
United States University of South Florida Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Gentuity, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performance Operator evaluation of performance via Likert scale Immediately after the procedure
Primary Technical performance Objective measurement of image clarity of the HF-OCT images by an independent core lab Up to 3 months following the procedure
Secondary Complete pullbacks Percentage of HF-OCT images with maximum clear image length Up to 3 months following the procedure
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