PMCF Study of Precise Pro Rx for Carotid Artery Disease
- Conditions
- Carotid Artery Stenosis
- Registration Number
- NCT07204678
- Lead Sponsor
- Cordis Corporation
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 187
- 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
- Women who were pregnant or lactating at the time of the procedure
- Pediatric subjects (<18 years of age) at the time of the procedure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Endpoint - Myocardial Infarction Through 5 years. All site-reported events of myocardial infarction
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 - 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
- Secondary Outcome Measures
Name Time Method