Status:
WITHDRAWN
ACHIEVE GRX Registry
Lead Sponsor:
Corindus Inc.
Conditions:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.
Detailed Description
This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Subject has a clinical indication for Peripheral Vascular Intervention (PVI).
- Subject is deemed appropriate for robotic-assisted PVI.
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.
Exclusion
- Failure/inability/unwillingness to provide informed consent.
- The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.
- Women who are pregnant.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04513613
Start Date
January 1 2022
End Date
January 1 2023
Last Update
April 23 2021
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