PMCF Study of Precise Pro Rx for Carotid Artery Disease

NCT ID: NCT07204678

Last Updated: 2026-01-06

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-30

Study Completion Date

2026-01-30

Brief Summary

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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

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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 is to evaluate the long-term (5-year) safety and performance of PRECISE PRO Rx Nitinol Stent System in subjects with stenotic lesions of the carotid arteries. The study is conducted in up to 15 European study sites in approximately 3 countries with high volume use of PRECISE PRO Rx. The enrollment and data collection takes approximately 4-6 months.

Conditions

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Carotid Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects treated with the PRECISE PRO Rx Nitinol Stent System

Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis

PRECISE PRO Rx Nitinol Stent System

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* Women who were pregnant or lactating at the time of the procedure
* Pediatric subjects (\<18 years of age) at the time of the procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis US Corp.

INDUSTRY

Sponsor Role lead

Rede Optimus Hospitalar SA

NETWORK

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nusrath Sultana

Role: STUDY_DIRECTOR

Cordis US Corp.

Locations

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University Hospital Tulln

Tulln, , Austria

Site Status

Countries

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Austria

Other Identifiers

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P21-7903

Identifier Type: -

Identifier Source: org_study_id

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