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NAVIGATE GRX Study

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ClinicalTrials.gov Identifier: NCT04883008
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.

Study Description
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Brief Summary:
The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: CorPath GRX with technIQ automated movements enabled (technIQ ON) Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).

Detailed Description:
This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.
Study Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Intervention
CorPath GRX with technIQ automated movements enabled (technIQ ON)
 Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist.
Control
CorPath GRX with technIQ automated movements disabled (technIQ OFF).
 Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled.
CTO Registry
CorPath GRX with technIQ automated movements enabled (technIQ ON) in subjects undergoing robotic-assisted PCI for chronic total occlusions (CTOs)
 Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist.


Outcome Measures
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Primary Outcome Measures :
  1. Major Clinical and Angiographic Complications (MCAC) [ Time Frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first. ]
    The rate of the combined MCAC endpoint (a composite of MACE and Major Clinical and Angiographic Complications) in the technIQ ON group is not significantly higher than in the technIQ OFF group.

  2. Technical Success [ Time Frame: During the Procedure ]
    Residual stenosis of <30% in all target lesions with final TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 by angiographic core lab analysis, AND absence of unplanned manual conversion.


Secondary Outcome Measures :
  1. PCI procedure time [ Time Frame: During the Procedure ]
    Time between insertion of guide catheter and final removal of guide catheter.

  2. Procedure success [ Time Frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first. ]
    The rate of procedure success in the technIQ ON group is not significantly lower than that in the technIQ OFF group.

  3. Major adverse cardiovascular events (MACE), [ Time Frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first. ]
    Reported as a composite and components of Cardiac Death, Target Vessel MI, and Target Vessel Revascularization (TVR).

  4. Major angiographic complications [ Time Frame: During the Procedure ]
    Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F).

  5. Guidewire Wiring Time [ Time Frame: During the Procedure ]
    The time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.

  6. Fluoroscopy Time to Cross Lesion [ Time Frame: During the Procedure ]
    The fluoroscopy time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.

  7. Contrast Used to Cross Lesion [ Time Frame: During the Procedure ]
    The amount of contrast (in ml) required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.

  8. Total Procedural Time [ Time Frame: During the Procedure ]
    The time from the start of the sheath insertion to complete removal of the final guide catheter.

  9. Total Fluoroscopy Time [ Time Frame: During the Procedure ]
    The total fluoroscopy time during the procedure as recorded by an Imaging System.

  10. Subject Radiation Exposure [ Time Frame: During the Procedure ]
    Dose-area-product (DAP) as recorded during the procedure

  11. Subject Radiation Dose [ Time Frame: During the Procedure ]
    air kerma (AK) as recorded during the procedure.

  12. Contrast Fluid Volume [ Time Frame: During the Procedure ]
    The total contrast volume used during the procedure.

  13. Planned Manual Conversion (PMC) [ Time Frame: During the Procedure ]
    Planned manual conversion (PMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was prespecified in the procedural plan (e.g., to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform, such as intravascular ultrasound or atherectomy devices). This will be assessed by a questionnaire.

  14. Unplanned Manual Conversion (UMC) [ Time Frame: During the Procedure ]
    Unplanned manual conversion (UMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was not prespecified in the procedural plan, and that was due to inability to navigate to the target lesion as intended, cross the target lesion as intended, treat the target lesion as intended, retract the CorPath GRX system as intended, or other CorPath system device malfunction; or any clinical condition that requires rapid medical intervention. This will be assessed by a questionnaire.

  15. Partial Manual Assistance (PMA) [ Time Frame: During the Procedure ]
    Partial manual assistance (PMA) is the use of manual techniques that were not prespecified in the procedural plan and do not meet the definition of unplanned manual conversion (e.g., unplanned use of manual techniques to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform). These will be assessed by a questionnaire.

  16. Device Malfunction [ Time Frame: During the Procedure ]
    The device malfunction will report the inadequacy of the medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. Investigators are instructed to report all device deficiencies and device malfunctions using the device malfunction form in the EDC.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The targeted population is subjects with coronary artery disease and with a clinical indication for PCI.
Criteria

Inclusion Criteria:

  • Male or nonpregnant female aged ≥ 20 years.
  • Patients with coronary artery disease with clinical indication for Percutaneous Coronary Intervention (PCI).
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  • Failure/inability/unwillingness to provide informed consent.
  • In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status or anatomic characteristics.
  • Acute STEMI within 72 hours pre-procedure.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883008


Contacts
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Contact: Marilynn Willkom +1-330-988-0356 marilynn.willkom@siemens-healthineers.com

Locations
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Poland
Intercard Sp. Z o.o. Recruiting
Nowy Sącz, Poland
Contact: Klaudia Z Proniewska    +48793060785    klaudia.proniewska@kcdk.pl   
Principal Investigator: Dariusz Dudek, MD, PhD         
Sponsors and Collaborators
Corindus Inc.
Investigators
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Principal Investigator: Jean Fajadet, MD Groupe Cardiovasculaire Interventionnel, Clinique Pasteur
More Information
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Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT04883008    
Other Study ID Numbers: 104-09466
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases