We are currently involved with many research projects specific to the blood vessels of the central nervous system. There are two main categories of the research we are involved with:

Humanitarian Use Devices

Humanitarian Use Devices are products that have been aproved bye the Food and Drug Administration (FDA) when a manufacturer chooses not to do formal research studies to test a product because the the product would be used to treat fewer than 4000 people a year. Before the FDA gives this exemption, it looks at information provided by the manufactuer and decides the the likely risks of using the device are reasonable compared to the the possible benefits of using this device dna compared to other treatment for the condition the device is treating. The Humanitarian Use Devices we are currently using in our department are:

Enterprise Stent: Used for the treatment of Wide-Necked Cerebral Artery Aneurysm. The sponsor company is Cordis Corporation, a Johnson & Johnson Company.

Neuroform Stent: Used for the treatment of Wide-Necked Cerebral Artery Aneurysm. The sponsor company is Boston Scientific

Wingspan Stent System and Gateway PTA Balloon Catheter: Used for the treatment of blood vessel narrowing in the brain. The sponsor company is Boston Scientific.

Current Research Projects

Medical research studies are voluntary and include only people who choose to take part. All studies we are involved with have been reviewed by an independent panel of medical personnel through the UCSF Committee on Human Research (CHR) Department. All studies require annual reivew of the previous year's research activity. After careful review of the data collected, the CHR may chose to extend the research project for another year. Some of the research projects we are currently involved with include:

SAPPHIRE WW Stenting and Angioplasy with Protection in Patients at High-Risk for Endarterectomy. The Sponsor Company is Cordis Corporation, a Johnson and Johnson company.

The purpose of this study is to collect information regarding the patient's medical experiences and conditions following treatment with the Cordis PRECISE Nitonol Stent System and ANGIOGUARD XP/RX Emboli Capture Guidewire System. The devices are already approved for use by the FDA are used to treat narrowing of cerebral blood vessels. This is a Post Market registry study only. A registry study means that the devies being used have already been approved by the FDA for use and that the purpose of the study is to assess the outcome of the use of the devices at 30 days and up to one year.

CAPTURE 2: Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated and Rare Events. The sponsor company is Guidant, an Abbott Company.

The purpose of this study is provde an ongoing post-market surveillance mechanism to document clinical outcomes after treatment for carotid artery disease. The RX ACCULINK Carotid Stent System and and the RX ACCUNET Embolic Protection Ststem. These devices are already approved for use by the FDA and no changes to standard medical care will occur as a result of participation in this study.

 

 

SAMMPRIS: Stent and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis

The purpose of this study is to determine wheter intensive medical therapy plus intracranial stenting is superior to intensive medical therapy along for preventing:

-any stroke or death within 30 days after study entry or

-ishcemic stroke in the territory of the symptomatic artery from day 31 to completion of Phase One of the study

Phase One of the study: National Institute of Neurological Diseases and Stroke (NINDS) of the National Institutes of Helath (NIH) funded, investigator-initiated, multi-center, randomized Phase III clinical trial.

Phase Two of the study: Boston Scientific Corporation funded longitudinal cohort of the patients in the stenting arm of Phase One.