Vis-Rx Post-Market Evaluation

Gentuity, LLC257 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

257

Conditions

Coronary Artery Disease

Interventions

HF-OCT Imaging with the Vis-Rx Micro-Imaging CatheterDEVICE

Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Clinical performance

Operator evaluation of performance via Likert scale

Time frame: Immediately after the procedure

Technical performance

Objective measurement of image clarity of the HF-OCT images by an independent core lab

Time frame: Up to 3 months following the procedure

Secondary Outcomes

Complete pullbacks

Percentage of HF-OCT images with maximum clear image length

Time frame: Up to 3 months following the procedure

Data from ClinicalTrials.gov

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