PMCF Study of Precise Pro Rx for Carotid Artery Disease (REAL-PRECISE)

Cordis US Corp.

Status

Invitation-only

Conditions

Carotid Artery Stenosis

Treatments

Device: PRECISE PRO Rx Nitinol Stent System

Study type

Observational

Funder types

NETWORK

Industry

Identifiers

NCT07204678

P21-7903

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

187 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

NOTE: This is a RETROSPECTIVE study designed to collect outcomes on subjects who were already treated with the study device.

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: