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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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