PRECISION GRX Registry

NCT ID: NCT03278301

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

952 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-27

Study Completion Date

2020-02-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corindus Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ehtisham Mahmud, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UC San Diego Health Sulpizio Cardiovascular Center

San Diego, California, United States

Site Status

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Spectrum Health Hospitals Fred and Lena Meijer Heart Center

Grand Rapids, Michigan, United States

Site Status

William Beaumont Hospital - Troy

Troy, Michigan, United States

Site Status

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

New York-Presbyterian Columbia University Medical Center

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

WakeMed Raleigh Campus

Raleigh, North Carolina, United States

Site Status

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Wellspan York Hospital

York, Pennsylvania, United States

Site Status

Jackson-Madison County General Hospital

Jackson, Tennessee, United States

Site Status

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, United States

Site Status

Baylor Scott and White All Saints Medical Center

Fort Worth, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

The Heart Hospital Baylor Plano

Plano, Texas, United States

Site Status

University of Virginia Health System University Hospital

Charlottesville, Virginia, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Albert Einstein Israelite Hospital

São Paulo, São Paulo, Brazil

Site Status

Apex Heart Institute

Ahmedabad, Gujarat, India

Site Status

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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United States Brazil India Singapore

Other Identifiers

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2017-001

Identifier Type: -

Identifier Source: org_study_id

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