Clinical Trial: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Abbott Vascular

Current Primary Outcome:

  • 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) [ Time Frame: 0 to 365 days ]
  • Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days [ Time Frame: 365 days ]


Original Primary Outcome: Composite rate of peri-procedural death and stroke, plus ipsilateral stroke between day 31 and 1 year (365 days) [ Time Frame: 1 year (365 days) ]

Current Secondary Outcome:

  • Death and All Stroke [ Time Frame: 30 Days ]
  • Composite of Peri-procedural Death and Stroke by Symptomatic Status [ Time Frame: 30 days ]
  • Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status [ Time Frame: 365 days ]
  • Composite of Peri-procedural Death and Stroke by Age [ Time Frame: 30 days ]
  • Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age [ Time Frame: 365 days ]
  • Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 30 days ]
    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.
  • Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 180 days ]
    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.
  • Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 365 days ]
    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.
  • Clinical Success [ Time Frame: 30 days ]
    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.


Original Secondary Outcome:

  • Composite of Peri-procedural Death and Stroke by Symptomatic Status [ Time Frame: 30 days ]
  • Ipsilateral stroke [ Time Frame: 2 years ]
  • Ipsilateral stroke [ Time Frame: 3 years ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 1 year ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 2 years ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 3 years ]
  • Annual rate of clinically driven target lesion revascularization (TLR) [ Time Frame: 3 years ]


Information By: Abbott Vascular

Dates:
Date Received: September 30, 2011
Date Started: October 2011
Date Completion:
Last Updated: July 13, 2016
Last Verified: July 2016