Clinical Trial: Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

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

Official Title: Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy

Brief Summary: The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of carotid artery disease in patients at increased risk for surgery.

Detailed Summary:
Sponsor: Cordis Corporation

Current Primary Outcome:

  • composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure [ Time Frame: 30-days post-procedure ]
  • The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure. [ Time Frame: Between day 31 and 12-months post-procedure. ]


Original Primary Outcome:

  • · composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure;
  • · The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure.


Current Secondary Outcome:

  • successful stent deployment at the target lesion in a variety of carotid morphologies
  • successful filter deployment and retrieval
  • <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation
  • endovascular access site complications, such as the need for surgical repair or blood transfusion
  • surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion
  • patency (< 50% restenosis) of the Cordis Nitinol Stent as determined by carotid ultrasound imaging within 48 hours, at six months, and one, two and three years post-procedure
  • independent neurologic assessments at 24 + 12 hours, thirty days, six months, and one, two and three years post-procedure (in addition to stroke scales, the development of any cranial nerve deficits will be recorded) - persistent neurologic deficits
  • thirty (30)-day and six (6)-month evaluation for disabling stroke [ Time Frame: Day 30 and 6 months ]
  • six (6)-month, one (1)-year, two (2)-year and three (3)-year composite of major adverse clinical events including death and ipsilateral stroke [ Time Frame: 6 month and 1, 2, 3yr ]
  • safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device
  • presence of trapped material as determined by the interventionalist's visual inspection of the ANGIOGUARD XP filter basket following recapture at the completion of the procedure
  • laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket


Original Secondary Outcome:

  • · successful stent deployment at the target lesion in a variety of carotid morphologies
  • · successful filter deployment and retrieval
  • · <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation
  • · endovascular access site complications, such as the need for surgical repair or blood transfusion
  • · surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion
  • · patency (< 50% restenosis) of the Cordis Nitinol Stent as determined by carotid ultrasound imaging within 48 hours, at six months, and one, two and three years post-procedure
  • · independent neurologic assessments at 24 + 12 hours, thirty days, six months, and one, two and three years post-procedure (in addition to stroke scales, the development of any cranial nerve deficits will be recorded) – persistent neurologic deficits
  • · thirty (30)-day and six (6)-month evaluation for disabling stroke
  • · six (6)-month, one (1)-year, two (2)-year and three (3)-year composite of major adverse clinical events including death and ipsilateral stroke
  • · safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device
  • · presence of trapped material as determined by the interventionalist’s visual inspection of the ANGIOGUARD XP filter basket following recapture at the completion of the procedure
  • · laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket


Information By: Cordis Corporation

Dates:
Date Received: October 3, 2005
Date Started: August 2000
Date Completion:
Last Updated: April 17, 2008
Last Verified: July 2007