PRECISION GRX Registry

A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Robotic-assisted PCI

Detailed Description

This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

• Study Type: Observational
• Enrollment (Actual): 952

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05652-900
      • Albert Einstein Israelite Hospital
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380059
      • Apex Heart Institute
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
• United States
  • California
    • San Diego, California, United States, 92037
      • UC San Diego Health Sulpizio Cardiovascular Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals Fred and Lena Meijer Heart Center
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital - Troy
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital Of Kansas City
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • New York-Presbyterian Columbia University Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Raleigh Campus
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center
    • York, Pennsylvania, United States, 17405
      • Wellspan York Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
    • Fort Worth, Texas, United States, 76104
      • Baylor Scott and White All Saints Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health System University Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease and with a clinical indication for PCI.

Description

Inclusion Criteria:

Candidates will be included in the study only if all of the following conditions are met:

1. Age ≥18 years;
2. Patients with coronary artery disease with clinical indication for PCI;
3. Patient deemed appropriate for robotic-assisted PCI; and
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

• Candidates will be excluded from the study if any of the following conditions are present:

  1. Failure/inability/unwillingness to provide informed consent; or
  2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).	Discharge or 72 hours post intervention, whichever comes first.
Technical Success	Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	Procedure
PCI Procedure Time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	Procedure
Fluoroscopy Time	Total Fluoroscopy Time during procedure will be captured.	Procedure
Patient Radiation Exposure	DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.	Procedure

Collaborators and Investigators

• Sponsor: Corindus Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 27, 2017
• Primary Completion (ACTUAL): February 6, 2020
• Study Completion (ACTUAL): February 6, 2020

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (ACTUAL): September 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2017-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No