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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Albany Medical College | OTHER |
| Asan Medical Center | OTHER |
| Baylor University |
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The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 - 18 months post coiling |
| Measure | Description | Time Frame |
|---|---|---|
| HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. | 6 - 18 months post coiling |
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Inclusion Criteria:
Exclusion Criteria:
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All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.
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| Name | Affiliation | Role |
|---|---|---|
| David F Kallmes, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28138062 | Derived | Brinjikji W, Amar AP, Delgado Almandoz JE, Diaz O, Jabbour P, Hanel R, Hui F, Kelly M, Layton KD, Miller JW, Levy E, Moran C, Suh DC, Woo H, Sellar R, Ho B, Evans A, Kallmes DF. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg. 2018 Jan;10(1):83-87. doi: 10.1136/neurintsurg-2016-012915. Epub 2017 Jan 30. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| Bronson Methodist Hospital | UNKNOWN |
| Capital Health, Canada | OTHER |
| The Cleveland Clinic | OTHER |
| Dalhousie University | OTHER |
| Fudan University | OTHER |
| Fort Sanders Regional Medical Center | UNKNOWN |
| JFK Medical Center, Florida | OTHER |
| Kobe City Medical Center | UNKNOWN |
| Methodist Research Institute, Indianapolis | OTHER |
| Medical University of South Carolina | OTHER |
| Providence Health & Services | OTHER |
| Scott and White Hospital & Clinic | OTHER |
| Stony Brook University | OTHER |
| Thomas Jefferson University | OTHER |
| Royal University Hospital Foundation | OTHER |
| University of California, Los Angeles | OTHER |
| University of Florida | OTHER |
| University of Maryland | OTHER |
| University of Oklahoma | OTHER |
| University of Southern California | OTHER |
| Washington University School of Medicine | OTHER |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |