Study Results
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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COMPLETED
952 participants
OBSERVATIONAL
2017-08-27
2020-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Corindus Inc.
INDUSTRY
Responsible Party
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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
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, 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
Montefiore Medical Center
The Bronx, New York, United States
WakeMed Raleigh Campus
Raleigh, North Carolina, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Wellspan York Hospital
York, Pennsylvania, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 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
Houston Methodist Hospital
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
University of Virginia Health System University Hospital
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Albert Einstein Israelite Hospital
São Paulo, São Paulo, Brazil
Apex Heart Institute
Ahmedabad, Gujarat, India
Tan Tock Seng Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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2017-001
Identifier Type: -
Identifier Source: org_study_id
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