Clinical trial NCT04883008: NAVIGATE GRX Study
Official title: A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The targeted population is subjects with coronary artery disease and with a clinical indication for PCI.

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.

Eligibility 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.

Primary outcomes:
measure: Major Clinical and Angiographic Complications (MCAC)
timeFrame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
measure: Technical Success
timeFrame: During the Procedure
Secondary outcomes:
measure: PCI procedure time
timeFrame: During the Procedure
measure: Procedure success
timeFrame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
measure: Major adverse cardiovascular events (MACE),
timeFrame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
measure: Major angiographic complications
timeFrame: During the Procedure
measure: Serious Adverse Events (SAE)
timeFrame: Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)
measure: Guidewire Wiring Time
timeFrame: During the Procedure
measure: Fluoroscopy Time to Cross Lesion
timeFrame: During the Procedure
measure: Contrast Used to Cross Lesion
timeFrame: During the Procedure
measure: Total Procedural Time
timeFrame: During the Procedure
measure: Total Fluoroscopy Time
timeFrame: During the Procedure
measure: Subject Radiation Exposure
timeFrame: During the Procedure
measure: Subject Radiation Dose
timeFrame: During the Procedure
measure: Contrast Fluid Volume
timeFrame: During the Procedure
measure: Planned Manual Conversion (PMC)
timeFrame: During the Procedure
measure: Unplanned Manual Conversion (UMC)
timeFrame: During the Procedure
measure: Partial Manual Assistance (PMA)
timeFrame: During the Procedure
measure: Device Malfunction
timeFrame: During the Procedure
Other outcomes:
Locations:
city: Nowy Sącz
country: Poland
facility: Intercard Sp. Z o.o.
Study officials:
affiliation: Groupe Cardiovasculaire Interventionnel, Clinique Pasteur
name: Jean Fajadet, MD
role: PRINCIPAL_INVESTIGATOR
References: