NAVIGATE GRX Study

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).; Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)

• Registration Number: NCT04883008
• Lead Sponsor: Corindus Inc.

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.

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 Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Study Start: 2021-06-14
• Primary Completion: 2022-02-04
• Study Completion: 2022-02-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	CorPath GRX with technIQ automated movements disabled (technIQ OFF).	CorPath GRX with technIQ automated movements disabled (technIQ OFF).
Intervention	CorPath GRX with technIQ automated movements enabled (technIQ ON)	CorPath GRX with technIQ automated movements enabled (technIQ ON)

Primary Outcome Measures

Name	Time	Method
Major Clinical and Angiographic Complications (MCAC)	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.
Technical Success	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

Name	Time	Method
PCI procedure time	During the Procedure	Time between insertion of guide catheter and final removal of guide catheter.
Major angiographic complications	During the Procedure	Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F).
Serious Adverse Events (SAE)	Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)	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
Guidewire Wiring Time	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.
Procedure success	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.
Major adverse cardiovascular events (MACE),	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).
Total Procedural Time	During the Procedure	The time from the start of the sheath insertion to complete removal of the final guide catheter.
Total Fluoroscopy Time	During the Procedure	The total fluoroscopy time during the procedure as recorded by an Imaging System.
Subject Radiation Exposure	During the Procedure	Dose-area-product (DAP) as recorded during the procedure
Planned Manual Conversion (PMC)	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.
Contrast Fluid Volume	During the Procedure	The total contrast volume used during the procedure.
Partial Manual Assistance (PMA)	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.
Fluoroscopy Time to Cross Lesion	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.
Contrast Used to Cross Lesion	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.
Subject Radiation Dose	During the Procedure	air kerma (AK) as recorded during the procedure.
Unplanned Manual Conversion (UMC)	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.
Device Malfunction	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.

Trial Locations

Locations (1)

Intercard Sp. Z o.o.; 🇵🇱 Nowy Sącz, Poland