Coronary Artery DiseaseNCT04883008
NAVIGATE GRX Study
An observational study of Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CorPath GRX with technIQ automated movements enabled (technIQ ON) and CorPath GRX with technIQ automated movements disabled (technIQ OFF).
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 14 Jun 2021to 7 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The targeted population is subjects with coronary artery disease and with a clinical indication for PCI.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions
The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- CorPath GRX with technIQ automated movements enabled (technIQ ON), CorPath GRX with technIQ automated movements disabled (technIQ OFF).
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorPath GRX with technIQ automated movements enabled (technIQ ON)Device
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).Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | CorPath GRX with technIQ automated movements enabled (technIQ ON) Receives: Device: CorPath GRX with technIQ automated movements enabled (technIQ ON) | |
| Control | CorPath GRX with technIQ automated movements disabled (technIQ OFF). Receives: Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
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.
Measured: During the Procedure
Secondary outcomes (17)
PCI procedure time
Time between insertion of guide catheter and final removal of guide catheter.
Measured: During the Procedure
Procedure success
The rate of procedure success in the technIQ ON group is not significantly lower than that in the technIQ OFF group.
Measured: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Major adverse cardiovascular events (MACE),
Reported as a composite and components of Cardiac Death, Target Vessel MI, and Target Vessel Revascularization (TVR).
Measured: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Major angiographic complications
Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F).
Measured: During the Procedure
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
Measured: Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)
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.
Measured: During the Procedure
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.
Measured: During the Procedure
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.
Measured: During the Procedure
Total Procedural Time
The time from the start of the sheath insertion to complete removal of the final guide catheter.
Measured: During the Procedure
Total Fluoroscopy Time
The total fluoroscopy time during the procedure as recorded by an Imaging System.
Measured: During the Procedure
Subject Radiation Exposure
Dose-area-product (DAP) as recorded during the procedure
Measured: During the Procedure
Subject Radiation Dose
air kerma (AK) as recorded during the procedure.
Measured: During the Procedure
Contrast Fluid Volume
The total contrast volume used during the procedure.
Measured: During the Procedure
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.
Measured: During the Procedure
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.
Measured: During the Procedure
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.
Measured: During the Procedure
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.
Measured: During the Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start14 Jun 2021
- Primary completion4 Feb 2022
- Study completion7 Feb 2022
Why it stopped: Sponsor business decision and low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Fajadet, MD, Principal investigator, Groupe Cardiovasculaire Interventionnel, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883008
- Sponsor's protocol ID
- 104-09466
- Status last verified
- Dec 2023
- First submitted
- 13 Apr 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ruggiero R, Khokhar AA, Siudak Z, Zlahoda-Huzior A, Zelias A, Dudek D. Evaluation of the CorPath-GRX technIQ automated movements during robotic-PCI (NAVIGATE GRX study). Cardiovasc Revasc Med. 2026 Jan;82:23-28. doi: 10.1016/j.carrev.2025.05.027. Epub 2025 May 29.
PubMed 40473553
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT04883008
- Acronym / sponsor ID
- 104-09466
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor business decision and low enrollment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)CorPath GRX with technIQ automated movements enabled (technIQ ON) |
| Control | – | Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).CorPath GRX with technIQ automated movements disabled (technIQ OFF). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The targeted population is subjects with coronary artery disease and with a clinical indication for PCI.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention |
| 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. | Device | Control |
Primary outcome
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.
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.
17 secondary outcomes
PCI procedure time
Time frame: During the Procedure
Procedure success
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
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.
Major angiographic complications
Time frame: During the Procedure
Serious Adverse Events (SAE)
Time frame: Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)
Guidewire Wiring Time
Time frame: During the Procedure
Fluoroscopy Time to Cross Lesion
Time frame: During the Procedure
Contrast Used to Cross Lesion
Time frame: During the Procedure
Total Procedural Time
Time frame: During the Procedure
Total Fluoroscopy Time
Time frame: During the Procedure
Subject Radiation Exposure
Time frame: During the Procedure
Subject Radiation Dose
Time frame: During the Procedure
Contrast Fluid Volume
Time frame: During the Procedure
Planned Manual Conversion (PMC)
Time frame: During the Procedure
Unplanned Manual Conversion (UMC)
Time frame: During the Procedure
Partial Manual Assistance (PMA)
Time frame: During the Procedure
Device Malfunction
Time frame: During the Procedure
Results and safety
The study was stopped early (reason given: Sponsor business decision and low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 40473553Ruggiero R, Khokhar AA, Siudak Z, Zlahoda-Huzior A, Zelias A, Dudek D. Evaluation of the CorPath-GRX technIQ automated movements during robotic-PCI (NAVIGATE GRX study). Cardiovasc Revasc Med. 2026 Jan;82:23-28. doi: 10.1016/j.carrev.2025.05.027. Epub 2025 May 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Fajadet, MD principal investigator
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision and low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.