Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Study Overview
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Brief Summary
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The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.

Official Title
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CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Conditions
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Carotid Artery Disease, Stroke, Amaurosis Fugax, Transient Ischemic Attack (TIA)

Intervention / Treatment
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* Device: RX Acculink Carotid Stent System (RX Acculink)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be ≥ 18 years of age. Subject does not have any condition that limits their anticipated survival to less than 3 years. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. Subject with all the following target vessel characteristics: Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. Absence of excessive vessel tortuosity that would impede delivery of devices. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RX Acculink Carotid Stent System (RX Acculink)<br>Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink. | Device: RX Acculink Carotid Stent System (RX Acculink)<br>* Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days) |  | 0 to 365 days | 
| Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days |  | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and All Stroke |  | 30 Days | 
| Composite of Peri-procedural Death and Stroke by Symptomatic Status |  | 30 days | 
| Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status |  | 365 days | 
| Composite of Peri-procedural Death and Stroke by Age |  | 30 days | 
| Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age |  | 365 days | 
| Freedom From Clinically Driven Target Lesion Revascularization | Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion. | 30 days | 
| Freedom From Clinically Driven Target Lesion Revascularization | Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion. | 180 days | 
| Freedom From Clinically Driven Target Lesion Revascularization | Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion. | 365 days | 
| Clinical Success | Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid, Stent, Carotid Endarterectomy