PRECISION GRX Post-Market Study

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

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-12

Study Completion Date

2020-10-09

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic PCI

All subjects treated with CorPath GRX during the PCI procedure.

Robotic-assisted PCI

Intervention Type DEVICE

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.

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

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No