NAVIGATE GRX Study

Coronary Artery Disease Clinical Trial

Official title:

A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04883008
• Other study ID #: 104-09466
• Status: Terminated
• Start date: June 14, 2021
• Est. completion date: February 7, 2022

Study information

• Verified date: December 2023
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: February 7, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Intercard Sp. Z o.o.	Nowy Sacz

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Clinical and Angiographic Complications (MCAC)	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.	72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Primary	Technical Success	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.	During the Procedure
Secondary	PCI procedure time	Time between insertion of guide catheter and final removal of guide catheter.	During the Procedure
Secondary	Procedure success	The rate of procedure success in the technIQ ON group is not significantly lower than that in the technIQ OFF group.	72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Secondary	Major adverse cardiovascular events (MACE),	Reported as a composite and components of Cardiac Death, Target Vessel MI, and Target Vessel Revascularization (TVR).	72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Secondary	Major angiographic complications	Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F).	During the Procedure
Secondary	Serious Adverse Events (SAE)	All Serious Adverse Events (SAEs) from the start of the CorPath GRX PCI procedure through 72 hours postprocedure or hospital discharge (whichever occurs) first will be summarized	Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)
Secondary	Guidewire Wiring Time	The time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.	During the Procedure
Secondary	Fluoroscopy Time to Cross Lesion	The fluoroscopy time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.	During the Procedure
Secondary	Contrast Used to Cross Lesion	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.	During the Procedure
Secondary	Total Procedural Time	The time from the start of the sheath insertion to complete removal of the final guide catheter.	During the Procedure
Secondary	Total Fluoroscopy Time	The total fluoroscopy time during the procedure as recorded by an Imaging System.	During the Procedure
Secondary	Subject Radiation Exposure	Dose-area-product (DAP) as recorded during the procedure	During the Procedure
Secondary	Subject Radiation Dose	air kerma (AK) as recorded during the procedure.	During the Procedure
Secondary	Contrast Fluid Volume	The total contrast volume used during the procedure.	During the Procedure
Secondary	Planned Manual Conversion (PMC)	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.	During the Procedure
Secondary	Unplanned Manual Conversion (UMC)	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.	During the Procedure
Secondary	Partial Manual Assistance (PMA)	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.	During the Procedure
Secondary	Device Malfunction	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.	During the Procedure