Status:
ENROLLING_BY_INVITATION
PMCF Study of Precise Pro Rx for Carotid Artery Disease
Lead Sponsor:
Cordis US Corp.
Collaborating Sponsors:
Rede Optimus Hospitalar SA
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate long-term clinical safety and performance of the PRECISE PRO RX Nitinol Stent System to treat stenotic lesions of the carotid arteries.
Detailed Description
The REAL-PRECISE study is a multi-center, non-randomized, observational analysis of retrospective data collected on subjects treated with PRECISE PRO Rx Nitinol Stent System. The purpose of this study...
Eligibility Criteria
Inclusion
- NOTE: This is a RETROSPECTIVE study designed to collect outcomes on subjects who were already treated with the study device.
- Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis
- If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data
Exclusion
- Women who were pregnant or lactating at the time of the procedure
- Pediatric subjects (\<18 years of age) at the time of the procedure
Key Trial Info
Start Date :
October 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT07204678
Start Date
October 30 2025
End Date
January 30 2026
Last Update
January 6 2026
Active Locations (1)
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1
University Hospital Tulln
Tulln, Austria, 3430