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

G

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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