PMCF Study of Precise Pro Rx for Carotid Artery Disease
NCT07204678 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 199
Last updated 2026-03-13
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.
Conditions
- Carotid Artery Stenosis
Interventions
- DEVICE
-
PRECISE PRO Rx Nitinol Stent System
The Cordis PRECISE PRO Rx Nitinol Stent System is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the carotid artery(ies). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The Cordis PRECISE PRO Rx Nitinol Stent System is indicated for use in patients with stenotic lesions of the carotid artery(ies).
Sponsors & Collaborators
-
Rede Optimus Hospitalar SA
collaborator NETWORK -
Cordis US Corp.
lead INDUSTRY
Principal Investigators
-
Nusrath Sultana · Cordis US Corp.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-30
- Primary Completion
- 2026-02-27
- Completion
- 2026-02-27
- FDA Device
- Yes
Countries
- Austria
- France
- Italy
Study Locations
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