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

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Treatment with aspirin at a dose of 81 or 325 mg per day was begun at least 72 hours before stenting or endarterectomy and was continued indefinitely in both study groups. Both groups received intraprocedural heparin to maintain a therapeutic activated partial-thromboplastin time of 250 to 300 seconds. Patients undergoing stenting received clopidogrel (75 mg per day) starting 24 hours before the procedure and continuing for two to four weeks thereafter. Patients undergoing endarterectomy did not receive clopidogrel

Outcomes

Type Measure Time Frame Safety Issue
Primary Cumulative incidence of a major cardiovascular event at one year: a composite of death, stroke or myocardial infarction within 30 days of intervention or ipsilateral stroke between 31 days and 1 year.
Secondary Target-vessel recanalization at one year, cranial nerve palsy, and complications at either the surgical or vascular access site.
Primary composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure 30-days post-procedure
Primary The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure. Between day 31 and 12-months post-procedure.
Secondary successful stent deployment at the target lesion in a variety of carotid morphologies
Secondary successful filter deployment and retrieval
Secondary <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation
Secondary endovascular access site complications, such as the need for surgical repair or blood transfusion
Secondary surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion
Secondary 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
Secondary 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
Secondary thirty (30)-day and six (6)-month evaluation for disabling stroke Day 30 and 6 months
Secondary six (6)-month, one (1)-year, two (2)-year and three (3)-year composite of major adverse clinical events including death and ipsilateral stroke 6 month and 1, 2, 3yr
Secondary safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device
Secondary 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
Secondary laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket

Sponsors