PMCF Study of Precise Pro Rx for Carotid Artery Disease

N/AEnrolling By InvitationNCT07204678

Cordis US Corp.187 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

187

Conditions

Carotid Artery Stenosis

Interventions

PRECISE PRO Rx Nitinol Stent SystemDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Tulln

Tulln, Austria

Outcomes

Primary Outcomes

Performance Endpoint - Technical Success

Achievement of a final residual stenosis of \<30% at the target lesion using any percutaneous method at the conclusion of the index procedure

Time frame: At the conclusion of the index procedure

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

A repeat revascularization procedure performed at the original treatment site due to restenosis of ≥50% at the target lesion (as confirmed by quantitative angiography) in the presence of symptoms or ≥80% in the absence of symptoms

Time frame: At 12 months

Safety Endpoint - All-Cause Mortality

All site-reported events of all-cause mortality

Time frame: Through 5 years

Safety Endpoint - Myocardial Infarction

All site-reported events of myocardial infarction

Time frame: Through 5 years.

Safety Endpoint - Major Stroke

A major stroke is defined as a cerebrovascular accident

Time frame: Through 5 years

Safety Endpoint - Minor Stroke

A minor stroke is defined as a transient ischemic attack

Time frame: Through 5 years

Safety Endpoint - Thrombosis

All site-reported events of thrombosis

Time frame: Through 5 years

Data from ClinicalTrials.gov

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