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Completed

NCT Number: NCT03870087

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 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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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fukuoka Sanno Hospital, Fukuoka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Failure/inability/unwillingness to provide informed consent, unless the EC has waived 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. Residual stenosis in the lesion(s) treated

    Time frame: Through end of subject's participation in the study, an average of up to 3 days.

    Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse cardiac events (MACE) as assessed by the Angiographic Core Laboratory (ACL).

  2. Technical Success

    Time frame: During 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. Major adverse cardiac events (MACE)

    Time frame: Through end of subject's participation in the study, an average of up to 3 days.

    MACE that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath GRX System.

  2. Overall Procedure Time

    Time frame: During procedure

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

  3. PCI Procedure Time

    Time frame: During procedure

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

  4. IVUS/OCT/IVUS-OCT Time (if used)

    Time frame: During procedure

    Defined as the total time measured from insertion of the imaging catheter [Intravascular Ultrasound (IVUS), Optical Coherence Tomography (OCT) or integrated IVUS-OCT (IVUS-OCT)] until the removal of the imaging catheter.

  5. Fluoroscopy Time

    Time frame: During procedure

    Total fluoroscopy utilized during the procedure as recorded by an Imaging System.

  6. Patient Radiation Exposure

    Time frame: During procedure

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

  7. Operator Radiation Exposure

    Time frame: During procedure

    Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure.

Sponsors and collaborators

Lead sponsor

Siemens Healthineers Endovascular Robotics, Inc.

Industry

Collaborators

  • Japan Medicalnext, Co

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
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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