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PRECISION GRX Post-Market Study - Japan

NCT03870087 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2020-10-19

No results posted yet for this study

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 in the first 231 patients treated with the CorPath device in Japan.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Japan Medicalnext, Co

    collaborator UNKNOWN

  • Corindus Inc.

    lead INDUSTRY

Principal Investigators

  • Masato Nakamura, MD · Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2020-10-09
Completion
2020-10-09
FDA Device
Yes

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870087 on ClinicalTrials.gov