Vis-Rx Post-Market Evaluation (Vis-Rx PME)

Gentuity

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT04533503

003175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

75 participants in 1 patient group

HF-OCT imaging

Description:

Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging

Treatment:

Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter