Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
50 participants
OBSERVATIONAL
2021-06-14
2022-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention
CorPath GRX with technIQ automated movements enabled (technIQ ON)
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Corindus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Fajadet, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur
Locations
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Intercard Sp. Z o.o.
Nowy Sącz, , Poland
Countries
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Other Identifiers
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104-09466
Identifier Type: -
Identifier Source: org_study_id