The SPIDER™ Embolic Protection Device Performance Evaluation in the Cartoid Artery during PTA and/or Stenting
- Volume 17 - Issue 9 - September, 2005
- Posted on: 8/1/08
- 0 Comments
- 9916 reads
In the aging population, stroke is the most common and disabling neurological disorder, with more than 500,000 annual strokes in the United States.1 Carotid artery stenosis is a significant risk factor for stroke. Surgical treatment for carotid artery stenosis has been the traditional standard of care.2 In the North American Symptomatic Carotid Endarterectomy Trial (NASCET), it was documented that carotid endarterectomy (CEA) is beneficial in reducing stroke risk in those patients with significant stenosis.3,4 CEA has a significant perioperative morbidity and mortality rate, the risk of which depends on the skill and experience of the surgeon and staff.3,4 Carotid artery stenting (CAS) is a nonsurgical way of unblocking the atherosclerotic carotid arteries. Embolic protection prevents particles that become dislodged during CAS from moving to the brain where they can cause stroke or death. Two recently completed studies, ARCHeR 2 and SAPPHIRE, compared CEA with CAS utilizing embolic protection in high surgical risk patients.5,6 In these trials, CAS utilizing embolic protection was found to be just as effective as, and much less invasive than, surgery in preventing stroke. The SAPPHIRE Trial was the first randomized study to compare CAS with embolic protection to CEA. This trial showed favorable results for the new procedure, determining the noninferiority of carotid artery angioplasty and stenting to carotid endarterectomy in the treatment of carotid artery stenosis.6
The PROTECT Trial, sponsored by ev3 Inc. (Plymouth, Minnesota) for CE Marking, evaluated the performance requirements of the SPIDER™ Embolic Protection Device in patients who were candidates for percutaneous transluminal angioplasty (PTA) and/or stenting. Qualified patients were treated with distal protection using the SPIDER Embolic Protection Device.
Patient selection. The PROTECT Trial enrolled 74 patients 18 years of age or older between November 2001 and September 2002 across five European study centers in three countries: Belgium, Germany and Italy. The appropriate local ethics committee approved the research protocol and informed consent. Written informed consent was obtained from all patients prior to enrollment. Table 1 summarizes the study parameters, including patient selection criteria, study design and patient enrollment.
Qualified patients presented with carotid artery stenosis suitable for femoral access percutaneous transluminal angioplasty (PTA) and/or stenting with distal protection. The patients included were either asymptomatic with a ? 70% lesion occlusion, or were symptomatic with a ? 50% lesion occlusion. The normal parallel portion of the internal carotid artery distal to the stenosis where the Capture Wire filter was placed was between ? 2.0 mm and ? 7.0 mm in diameter. Patients with a total occlusion of the target vessel during the pre-procedure angiography were not included. Patients who experienced an acute stroke within 14 days prior to the procedure, as well as patients with a major residual neurologic deficit (stroke scales: Barthel ? 60, NIH ? 15, or Rankin > 3) in a previously defined territory at pre-procedure neurological exam were excluded. Any patients with intolerance to heparin, aspirin or clopidogrel were also excluded. A complete list of exclusion criteria is presented in Table 2.