Carotid Artery Stenosis
Conditions
Keywords
Carotid artery stenosis, PRECISE PRO Rx Nitinol Stent System
Brief 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.
Detailed 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.
Interventions
DEVICEPRECISE PRO Rx Nitinol Stent System
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).
Sponsors
Cordis US Corp.
Rede Optimus Hospitalar SA
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
* Women who were pregnant or lactating at the time of the procedure * Pediatric subjects (\<18 years of age) at the time of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Endpoint - Technical Success | At the conclusion of the index procedure | Achievement of a final residual stenosis of \<30% at the target lesion using any percutaneous method at the conclusion of the index procedure |
| Performance Endpoint - Target Lesion Revascularization (TLR) at 12 months | 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 |
| Safety Endpoint - All-Cause Mortality | Through 5 years | All site-reported events of all-cause mortality |
| Safety Endpoint - Myocardial Infarction | Through 5 years. | All site-reported events of myocardial infarction |
| Safety Endpoint - Major Stroke | Through 5 years | A major stroke is defined as a cerebrovascular accident |
| Safety Endpoint - Minor Stroke | Through 5 years | A minor stroke is defined as a transient ischemic attack |
| Safety Endpoint - Thrombosis | Through 5 years | All site-reported events of thrombosis |
Countries
Austria, France, Italy
Contacts
STUDY_DIRECTORNusrath Sultana
Cordis US Corp.
Outcome results
None listed