Brain Aneurysm Clinical Trial
— SCENTOfficial title:
The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)
NCT number | NCT01716117 |
Other study ID # | SP-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 25, 2012 |
Est. completion date | July 7, 2022 |
Verified date | December 2022 |
Source | Stryker Neurovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
Status | Completed |
Enrollment | 213 |
Est. completion date | July 7, 2022 |
Est. primary completion date | December 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 19 to 80 years - Subject or legal representative is willing and able to give informed consent - Subject has a single targeted intracranial aneurysm - Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up Exclusion Criteria: - Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia - Known history of life threatening allergy to contrast dye - Known allergy to nickel, chromium cobalt, tungsten or platinum - Subject has documented resistance to clopidogrel/Plavix - Major surgery within previous 30 days or planned in the next 120 days after enrollment date - Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date - Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date - Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device - Any previous coiling where it would interfere with the placement and proper apposition of the device - Platelet count less than 100,000 cells/mm3 or known platelet dysfunction - More than one intracranial aneurysm (IA) that requires treatment within 12 months - Asymptomatic extradural aneurysms requiring treatment - Contraindication to CT scan or MRI - Severe neurological deficit that renders the subject incapable of living independently - Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days) - Evidence of active infection at the time of treatment - Dementia or psychiatric problem that prevents the patient from completing required follow up - Co-morbid conditions that may limit survival to less than 24 months - Serum creatinine greater or equal to 2.5 mg/dL - Female subjects who are pregnant or planning to become pregnant within the study period - Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis - Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm - Other known serious concurrent medical conditions - History of intracranial vasospasm not responsive to medical therapy - Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region - Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions - Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date - Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm - Inability to understand the study or a history of non-compliance with medical advice - Current use of illicit substance - Enrollment in another trial involving an investigational product - Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran) |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC St Radboud | Nijmegen | |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University at Buffalo | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Texas - Southwestern | Dallas | Texas |
United States | University of Florida | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of California | Irvine | California |
United States | Lyerly Neurosurgery/Baptist Health System | Jacksonville | Florida |
United States | Mayo Clinic - Florida | Jacksonville | Florida |
United States | The University of Kansas Medical Center | Kansas City | Kansas |
United States | Fort Sanders Medical Center | Knoxville | Tennessee |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | The Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Columbia University | New York | New York |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Mayo Clinic - Minnesota | Rochester | Minnesota |
United States | University of Utah | Salt Lake City | Utah |
United States | Santa Barbara Cottage Hospital | Santa Barbara | California |
United States | Tampa General Hospital | Tampa | Florida |
United States | University of Massachusetts Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Stryker Neurovascular |
United States, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up | Patients with minor strokes through 12 months | 12 Months | |
Other | Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age = 65 Years Versus < 65 Years in mITT Population | Primary effectiveness by age group | 12 Months | |
Other | CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population | Primary effectiveness by intracranial aneurysm size | 12 Months | |
Other | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | Number of devices implanted in subjects by study population | 12 Months | |
Primary | mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit. | Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit. | 12 months | |
Primary | mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. | Subjects experiencing neurologic death or major ipsilateral stroke through 12 months. | 12 months | |
Secondary | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse). | 12 months |
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