Clinical Trial: Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

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

Official Title: Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)

Brief Summary: The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.

Detailed Summary:
Sponsor: Abbott Vascular

Current Primary Outcome: Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years. [ Time Frame: 3 years ]

Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.


Original Primary Outcome: Composite of any stroke, myocardial infarction and death during the 30-day post procedural period and ipsilateral strokes between 31 and 365 days

Current Secondary Outcome:

  • Acute Device Success [ Time Frame: Post-procedure ]
    Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.
  • Procedural Success [ Time Frame: 30 Days ]
    Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.
  • Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax [ Time Frame: ≤30 days ]
    Includes only each subject's first occurrence of each event.
  • Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years. [ Time Frame: 3 years ]


Original Secondary Outcome:

  • 0-30 days Post-procedure:
  • Acute Device Success
  • Procedural success12 months
  • Post-procedure:
  • Freedom from clinically driven target lesion revascularization at 12 months


Information By: Abbott Vascular

Dates:
Date Received: November 20, 2006
Date Started: November 2006
Date Completion:
Last Updated: May 17, 2012
Last Verified: May 2012