Vis-Rx Post-Market Evaluation

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter

• Registration Number: NCT04533503
• Lead Sponsor: Gentuity, LLC

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-08-31
• Study Start: 2021-02-22
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HF-OCT imaging	HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter	Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging

Primary Outcome Measures

Name	Time	Method
Clinical performance	Immediately after the procedure	Operator evaluation of performance via Likert scale
Technical performance	Up to 3 months following the procedure	Objective measurement of image clarity of the HF-OCT images by an independent core lab

Secondary Outcome Measures

Name	Time	Method
Complete pullbacks	Up to 3 months following the procedure	Percentage of HF-OCT images with maximum clear image length

Trial Locations

Locations (3)

University of South Florida; 🇺🇸 Tampa, Florida, United States

Baptist Health Lexington; 🇺🇸 Lexington, Kentucky, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States