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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533503
Recruitment Status : Not yet recruiting
First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HF-OCT imaging
Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging
Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Complete pullbacks [ Time Frame: Up to 3 months following the procedure ]
    Percentage of HF-OCT images with maximum clear image length



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533503


Contacts
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Contact: Rachel L. Currie, MPH 919-922-7296 rcurrie@broadstreetclinical.com

Sponsors and Collaborators
Gentuity, LLC
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Responsible Party: Gentuity, LLC
ClinicalTrials.gov Identifier: NCT04533503    
Other Study ID Numbers: 003175
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases