Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH) (BEACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00316108|
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : August 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Diseases Stroke Cerebral Arteriosclerosis||Device: WALLSTENT® Endoprosthesis™||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||747 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||November 2007|
|Experimental: Arm 1||
Device: WALLSTENT® Endoprosthesis™
Carotid Artery Stent
- 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 [ Time Frame: 1 year ]
- peri-procedural (within 30 days of procedure) death, stroke, Q-wave myocardial infarction [ Time Frame: Within 30 days of Procedure ]
- late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up. [ Time Frame: 1 year ]
- Peri-procedural morbidity and mortality [ Time Frame: Within 30 Days of procedure ]
- FilterWire EX and EZ System technical success [ Time Frame: Post procedure ]
- Carotid Wallstent technical success [ Time Frame: Post Procedure ]
- system technical success [ Time Frame: Post Procedure ]
- angiographic success [ Time Frame: Post Procedure ]
- procedural success [ Time Frame: Post Procedure ]
- 30-day clinical success [ Time Frame: 30 days post procedure ]
- peri-procedural overall morbidity [ Time Frame: 30 days post procedure ]
- one-year clinical success [ Time Frame: 1 Year post procedure ]
- late stroke, transient ischemic attack (TIA) and death. [ Time Frame: 1 year post procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316108
|Principal Investigator:||Christopher White, MD||Ochsner Health System|
|Principal Investigator:||Sriram Iyer, MD||Lenox Hill Heart and Vascular Institute|
|Study Director:||Pamela G Grady, Ph.D||Boston Scientific Corporation|