CompletedNot Applicable

PMCF Study of Precise Pro Rx for Carotid Artery Disease

Austria, France, Italy199 participantsStarted 2025-10-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Performance Endpoint - Technical Success

Timeframe: At the conclusion of the index procedure

Performance Endpoint - Target Lesion Revascularization (TLR) at 12 months

Timeframe: At 12 months

Safety Endpoint - All-Cause Mortality

Timeframe: Through 5 years

Safety Endpoint - Myocardial Infarction

Timeframe: Through 5 years.

Safety Endpoint - Major Stroke

Timeframe: Through 5 years

Safety Endpoint - Minor Stroke

Timeframe: Through 5 years

Safety Endpoint - Thrombosis

Timeframe: Through 5 years

Trial details

NCT IDNCT07204678

SponsorCordis US Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-27

View on ClinicalTrials.gov More Carotid Artery Stenosis trials