Post Market Clinical Follow-up Study of the Precise Pro Rx Nitinol Stent System in the Treatment of Carotid Artery Disease (REAL-PRECISE)

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Public Health Interest of the Project:
Carotid artery stenosis is a major cause of ischemic stroke, a leading driver of death and long-term disability. This Post-Market Clinical Follow-up (PMCF) study will generate five-year, real-world evidence on the safety and performance of the PRECISE PRO Rx Nitinol Stent System in patients with stenotic carotid lesions. By characterizing long-term outcomes, such as stroke and restenosis rates, reinterventions, and serious device- or procedure-related adverse events, the study will strengthen long term use of the PRECISE PRO Rx Nitinol Stent System. The resulting evidence serves the public interest by safe guarding patients, supporting regulatory oversight and quality improvement, and helping understand strokes and through better, data-driven care.

Study Objectives:
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.

Study Design:
This is a multi-center, non-randomized, observational analysis of retrospective data collected on subjects treated with PRECISE PRO Rx Nitinol Stent System.

Subject Selection for Data Mining:
For data mining purposes, the following criteria will apply in determining which subjects to include in the study:
1. Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis
2. 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

It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first. Subjects not included because follow-up information is unavailable will be documented, wherever possible, with respect to demographics and presenting disease state to determine whether they are similar to subjects with follow-up that are enrolled.

For data mining purposes, the following criteria will apply in determining which subjects to exclude in the study:
1. Women who were pregnant or lactating at the time of the procedure.
2.Pediatric subjects (<18 years of age) at the time of the procedure.