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Completed

NCT Number: NCT04533503

Vis-Rx Post-Market Evaluation

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Clinical performance

    Time frame: Immediately after the procedure

    Operator evaluation of performance via Likert scale

  2. Technical performance

    Time frame: Up to 3 months following the procedure

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

Secondary outcomes

  1. Complete pullbacks

    Time frame: Up to 3 months following the procedure

    Percentage of HF-OCT images with maximum clear image length

Sponsors and collaborators

Lead sponsor

Gentuity, LLC

Industry

Registry information

Official study title

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

Acronym: Vis-Rx PME

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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