Clinical Trials

3 studies in Intracranial Aneurysm

1. PRET: Patients Prone to Recurrence After Endovascular Treatment Rochester, MN View Summary
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   PRET: Patients Prone to Recurrence After Endovascular Treatment

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.

   NCT ID:

   NCT00626912

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   Who can I contact for additional information about this study?

   Rochester: Leigh Gray
                       
   
   
   

2. Registry for Study of Coils in Intracranial Aneurysms Jacksonville, FL Rochester, MN View Summary
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   Registry for Study of Coils in Intracranial Aneurysms

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. This registry is designed to achieve 80% power to detect a minimally clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms compared with bare platinum coils. Based on recent, prospective, randomized trials assessing both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates, respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically, a "minimally clinically relevant difference" is on the order of a 30% diminution in a given undesirable outcome. As such, the registry is well powered to detect this minimally clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils versus 25% for the historical control group). Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. Success of this aim is defined as ease of placement of the HydroSoft device, without need for coil removal and subsequent "finishing" with a bare platinum coil. Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is associated with risks of thromboembolism similar to that with other coil types, on the order of 3-5% or less.

   NCT ID:

   NCT01000675

   IRB Number:

   09-002933

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   Who can I contact for additional information about this study?

   Rochester: Beth B Connelly 507-538-3928
                       
   
   
   

3. Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms Jacksonville, FL Rochester, MN View Summary
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   Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The objective of this study is to determine safety and effectiveness of the Surpass NeuroEndoGraft System (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass System is a flow diverter. It is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease in neurological death or ipsilateral stroke in patients with large or giant wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if treatment with the flow-diverter results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery at one year.

   NCT ID:

   NCT01716117

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   Who can I contact for additional information about this study?

   Rochester: Beth Connelly, CCRP
                       
   
   Jacksonville: Jessie Sperrazza