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

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • RX Acculink Carotid Stent System (RX Acculink) Device
    Intervention Desc: Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
    ARM 1: Kind: Experimental
    Label: RX Acculink Carotid Stent System
    ARM 2: Kind: Experimental
    Label: RX Acculink Carotid Stent System (RX Acculink)
    Description: Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite rate of peri-procedural death and stroke, plus ipsilateral stroke between day 31 and 1 year (365 days) 1 year (365 days) Yes
Secondary Composite of peri-procedural death and stroke by symptomatic status 30 days Yes
Secondary Ipsilateral stroke 2 years No
Secondary Peri-procedural death and stroke plus ipsilateral stroke for octogenarians 1 year Yes
Secondary Annual rate of clinically driven target lesion revascularization (TLR) 3 years No
Primary 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) 1 year (365 days) Yes
Primary Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days 365 days Yes
Secondary Death and All Stroke 30 Days Yes
Secondary Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status 365 days Yes
Secondary Composite of Peri-procedural Death and Stroke by Age 30 days Yes
Secondary Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age 365 days Yes
Secondary Freedom From Clinically Driven Target Lesion Revascularization 30 days Yes
Secondary Clinical Success 30 days Yes

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