PRECISION GRX Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278301
• Other study ID #: 2017-001
• Status: Completed
• Start date: August 27, 2017
• Est. completion date: February 6, 2020

Study information

• Verified date: October 2020
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Robotic-assisted PCI
The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Locations

Country	Name	City	State
Brazil	Albert Einstein Israelite Hospital	São Paulo	Sao Paulo
India	Apex Heart Institute	Ahmedabad	Gujarat
Singapore	Tan Tock Seng Hospital	Singapore
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia Health System University Hospital	Charlottesville	Virginia
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Baylor Scott and White All Saints Medical Center	Fort Worth	Texas
United States	Spectrum Health Hospitals Fred and Lena Meijer Heart Center	Grand Rapids	Michigan
United States	Houston Methodist Hospital	Houston	Texas
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	New York-Presbyterian Columbia University Medical Center	New York	New York
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	WakeMed Raleigh Campus	Raleigh	North Carolina
United States	UC San Diego Health Sulpizio Cardiovascular Center	San Diego	California
United States	University of Washington Medical Center	Seattle	Washington
United States	William Beaumont Hospital - Troy	Troy	Michigan
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Wellspan York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Countries where clinical trial is conducted

United States,  Brazil,  India,  Singapore, 

Outcome

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