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| Name | Class |
|---|---|
| Rede Optimus Hospitalar SA | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with the PRECISE PRO Rx Nitinol Stent System | Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECISE PRO Rx Nitinol Stent System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | At 12 months |
| Safety Endpoint - All-Cause Mortality | All site-reported events of all-cause mortality | Through 5 years |
| Safety Endpoint - Myocardial Infarction | All site-reported events of myocardial infarction | Through 5 years. |
| Safety Endpoint - Major Stroke | A major stroke is defined as a cerebrovascular accident | Through 5 years |
| Safety Endpoint - Minor Stroke | A minor stroke is defined as a transient ischemic attack | Through 5 years |
| Safety Endpoint - Thrombosis | All site-reported events of thrombosis | Through 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Stent Patency | The stent patency is defined as 30% stenosis immediately post-stent placement and < 50% stenosis long-term | Through 5 years |
| All adverse events | All adverse events reported by sites |
NOTE: This is a RETROSPECTIVE study designed to collect outcomes on subjects who were already treated with the study device.
Inclusion Criteria:
Exclusion Criteria:
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Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis.
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| Name | Affiliation | Role |
|---|---|---|
| Nusrath Sultana | Cordis US Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tulln | Tulln | 3430 | Austria | |||
| Hospital Pellegrin Bordeaux |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Through 5 years |
| In-Stent Restenosis (ISR) | All site-reported events of In-Stent Restenosis (ISR) evaluated through any imaging assessment performed | Through 5 years |
| Bordeaux |
| France |
| Pineta Grande Hospital | Castel Volturno | Italy |
| I.R.C.C.S. San Donato Polyclinic | Milan | Italy |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |