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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

Tracking Information
First Submitted Date August 25, 2020
First Posted Date August 31, 2020
Last Update Posted Date August 31, 2020
Estimated Study Start Date October 1, 2020
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2020)
  • Clinical performance [ Time Frame: Immediately after the procedure ]
    Operator evaluation of performance via Likert scale
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 28, 2020)		 Complete pullbacks [ Time Frame: Up to 3 months following the procedure ]
Percentage of HF-OCT images with maximum clear image length
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vis-Rx Post-Market Evaluation
Official Title Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures
Condition Coronary Artery Disease
Intervention Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
Study Groups/Cohorts HF-OCT imaging
Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging
Intervention: Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 28, 2020)		 50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rachel L. Currie, MPH 919-922-7296 rcurrie@broadstreetclinical.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04533503
Other Study ID Numbers 003175
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gentuity, LLC
Study Sponsor Gentuity, LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Gentuity, LLC
Verification Date August 2020