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PRECISION GRX Post-Market Study - Japan | Clinical Trials | Clareo Health

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COMPLETEDNCT03870087

PRECISION GRX Post-Market Study - Japan

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 guide...

Lead sponsor: Siemens Healthineers Endovascular Robotics, Inc.•8 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Siemens Healthineers Endovascular Robotics, Inc.

Collaborators

Japan Medicalnext, Co

This is a single-arm, open-label, multi-center patient registry in Japan 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.

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Age ≥ 20 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, unless the EC has waived informed consent.

Exclusion Criteria

•1. Failure/inability/unwillingness to provide informed consent, unless the EC has waived informed consent; or
•2. The Investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 19, 2020Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment242

Start dateApr 2019

Last updatedOct 19, 2020

Condition

Coronary Artery Disease

Locations shown

Fukuoka Sanno Hospital

Fukuoka, Fukuoka

Kurume University Hospital

Kurume, Fukuoka

Nayoro City General Hospital

Nayoro, Hokkaido

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2020Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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