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OpenTrials
Completed

NCT Number: NCT03278301

PRECISION GRX Registry

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albert Einstein Israelite Hospital, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Candidates will be included in the study only if all of the following conditions are met:

  • Age ≥18 years;
  • Patients with coronary artery disease with clinical indication for PCI;
  • Patient deemed appropriate for robotic-assisted PCI; and
  • 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:
  • Failure/inability/unwillingness to provide informed consent; or
  • The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Treatment and study plan

Robotic-assisted PCI

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.

Primary outcomes

  1. Clinical Success

    Time frame: Discharge or 72 hours post intervention, whichever comes first.

    Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).

  2. Technical Success

    Time frame: Procedure

    Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.

Secondary outcomes

  1. Overall Procedure Time

    Time frame: Procedure

    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

  2. PCI Procedure Time

    Time frame: Procedure

    Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

  3. Fluoroscopy Time

    Time frame: Procedure

    Total Fluoroscopy Time during procedure will be captured.

  4. Patient Radiation Exposure

    Time frame: Procedure

    DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.

Sponsors and collaborators

Lead sponsor

Siemens Healthineers Endovascular Robotics, Inc.

Industry

Registry information

Official study title

A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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