The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be less than or equal to that of objective performance criteria (OPC) derived from historic controls undergoing surgical intervention with a carotid endarterectomy (CEA).
Stroke is the third leading cause of death in this country with approximately 600,000 new stroke cases each year. Mortality rates as high as 40 percent have been reported for stroke as a result of ischemia associated with the carotid distribution. Currently, the primary therapy for carotid artery occlusive disease is carotid endarterectomy (CEA) or the surgical removal of atheromatous material from inside the artery.
Although CEA is an effective treatment for the majority of patients with carotid occlusive disease, there remains a need for a treatment option for those patients with significant surgical risk factors. These patients have been shown to have much higher rates of morbidity and mortality. There are approximately 50,000-70,000 patients each year who are considered poor surgical candidates. These patients present with either one or more anatomical or co-morbid conditions and have a one-year stroke and death rate of up to 15% with traditional surgical treatment.
Carotid artery stenting (CAS) has been reported by numerous single-center trials to be feasible in the treatment of carotid artery stenosis. Moreover, the risk benefit ratio has been suggested to be the largest in those patients with a higher risk profile for the CEA treatment option.
This trial will study the effects of percutaneous intervention using the Monorail™ Carotid Wallstent® Endoprosthesis (Carotid Wallstent) in conjunction with the FilterWire System distal protection device (FilterWire EX and EZ) on rates of common peri-procedural complications as well as on long-term outcomes as compared to historical outcomes of patients undergoing CEA.
- Stent, carotid Procedure/Surgery
Intervention Desc: Intravascular procedure to maintain carotid artery patency
- WALLSTENT® Endoprosthesis™ Device
Intervention Desc: Carotid Artery Stent ARM 1: Kind: Experimental Label: Arm 1
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
Patients underwent carotid stenting with the study device. Clinical follow up is at 1, 6, and 12 months post-procedure, and yearly for four years thereafter.
|Type||Measure||Time Frame||Safety Issue|
|Primary||One year composite endpoint, defined as cumulative morbidity & mortality.|
|Secondary||Peri-procedural morbidity and mortality; FilterWire EX and EZ System technical success; Carotid Wallstent technical success; system technical success; angiographic success; procedural success; 30-day clinical success; peri-procedural overall morbidity; one-year clinical success; late stroke, transient ischemic attack (TIA) and mortality.|
|Primary||The primary endpoint is one-year morbidity and mortality, defined as the cumulative incidence of any non Q-wave myocardial infarction within the 24 hours following carotid stenting||1 year||Yes|
|Primary||peri-procedural (within 30 days of procedure) death, stroke, Q-wave myocardial infarction||Within 30 days of Procedure||Yes|
|Primary||late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up.||1 year||Yes|
|Secondary||Peri-procedural morbidity and mortality||Within 30 Days of procedure||Yes|
|Secondary||FilterWire EX and EZ System technical success||Post procedure||Yes|
|Secondary||Carotid Wallstent technical success||Post Procedure||Yes|
|Secondary||system technical success||Post Procedure||Yes|
|Secondary||angiographic success||Post Procedure||Yes|
|Secondary||procedural success||Post Procedure||Yes|
|Secondary||30-day clinical success||30 days post procedure||Yes|
|Secondary||peri-procedural overall morbidity||30 days post procedure||Yes|
|Secondary||one-year clinical success||1 Year post procedure||Yes|
|Secondary||late stroke, transient ischemic attack (TIA) and death.||1 year post procedure||Yes|