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The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤ 12 mm for treatment in vessel diameters between 1.75-5.0mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surpass Evolve Flow Diverter System | Experimental | This is a prospective single arm study in which all subjects who present for flow diverter implantation, provide informed consent, and meet inclusion/exclusion criteria may receive treatment (Surpass Evolve Flow Diverter). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surpass Evolve Flow Diverter System | Device | The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | The primary effectiveness endpoint of this study is a composite of 100% occlusion (Raymond 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (>50% stenosis), per independent core lab assessment of digital subtraction angiography (DSA) images acquired at 12 months (± 3 months) post-procedure, and with no target aneurysm retreatment. | 12 months (± 3 months) post procedure |
| Primary Safety Endpoint | The primary safety endpoint of this study is neurologic death, or disabling stroke at 12 months as adjudicated by an independent Clinical Events Committee (CEC). | 12 Months (± 3 months) post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoints | The secondary safety endpoints will be evaluated throughout the study, and are as follows:
| 3 Year Follow-Up |
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Inclusion Criteria:
Age is ≥ 18 and ≤ 80 years
Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
Has a parent vessel diameter ≥ 1.75 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed
Has multiple increased risk factors for intracranial (IA) aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam S Arthur, MD | Semmes Murphy Clinic | Principal Investigator |
| Vitor M Pereira, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIGNITY HEALTH/ Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| St. Joseph's Hospital |
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| Tucson |
| Arizona |
| 85711 |
| United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery | Jacksonville | Florida | 32207 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Baptist Healthcare System, Inc./Baptist Health | Lexington | Kentucky | 40503 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| University of Massachusetts | North Worcester | Massachusetts | 01655 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Robert Wood Johnson University Medical Center | New Brunswick | New Jersey | 08901 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| ICAHN School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Stony Brook | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 77555 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Geisinger Clinic | Wilkes-Barre | Pennsylvania | 17822 | United States |
| Semmes Murphey Clinic/ University of Tennessee Health Sciences Center | Memphis | Tennessee | 38120 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Valley Baptist Health System, Harlingen | Harlingen | Texas | 78550 | United States |
| University of Utah | Salt Lake City | Utah | 84134 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Liverpool Hospital | Liverpool | New South Wales | NSW 2170 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Perth | 2170 | Australia |
| Gold Coast Hospital & Health Service/ Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| St. Michael's Hospital - Toronto | Toronto | Ontario | M5B 1W8 | Canada |
| University Health Network/ Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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