Brain Aneurysm
Conditions
Keywords
Large aneurysm, Giant aneurysm, Wide neck aneurysm
Brief summary
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).
Detailed description
The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (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 Flow Diverter 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 results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery, or requires retreatment of the aneurysm through 12 months.
Interventions
DEVICESurpass Flow Diverter
Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.
Sponsors
Stryker Neurovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The SCENT Trial is a multi-center, prospective, non-randomized trial.
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months | 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. |
| mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. | 12 months | Subjects experiencing neurologic death or major ipsilateral stroke through 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | 12 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up | 12 Months | Patients with minor strokes through 12 months |
| Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | 12 Months | Number of devices implanted in subjects by study population |
| Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population | 12 Months | Primary effectiveness by age group |
| CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population | 12 Months | Primary effectiveness by intracranial aneurysm size |
Countries
Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surpass Flow Diverter (mITT) The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted. | 180 |
| Roll-In An additional 45 Roll-In subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 Roll-In and Enrolled but Not Treated subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes. | 33 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Roll-In | Surpass Flow Diverter (mITT) |
|---|---|---|---|
| Age | 62.0 years | 65.0 years | 61.5 years |
| Age, Continuous | 61.2 years STANDARD_DEVIATION 10.1 | 62.4 years STANDARD_DEVIATION 11.1 | 61.0 years STANDARD_DEVIATION 9.9 |
| Body Mass Index (BMI) | 27.0 lbs/in^2 | 26.0 lbs/in^2 | 27.0 lbs/in^2 |
| Height | 65.0 inches (in) | 64.2 inches (in) | 65.0 inches (in) |
| Race/Ethnicity, Customized American Indian/Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 33 Participants | 7 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 187 Participants | 29 Participants | 158 Participants |
| Race/Ethnicity, Customized Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 6 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 162 Participants | 22 Participants | 140 Participants |
| Sex: Female, Male Female | 194 Participants | 29 Participants | 165 Participants |
| Sex: Female, Male Male | 19 Participants | 4 Participants | 15 Participants |
| Smoking Status/Alcohol Use Current Consumer of Alcohol | 103 Participants | 12 Participants | 91 Participants |
| Smoking Status/Alcohol Use Current Smoker | 46 Participants | 10 Participants | 36 Participants |
| Smoking Status/Alcohol Use Past Smoker | 90 Participants | 11 Participants | 79 Participants |
| Weight | 164.2 pounds (lbs) STANDARD_DEVIATION 39.1 | 149.6 pounds (lbs) | 158.4 pounds (lbs) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 180 | 2 / 33 |
| other Total, other adverse events | 129 / 180 | 24 / 33 |
| serious Total, serious adverse events | 54 / 180 | 17 / 33 |
Outcome results
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.
Time frame: 12 months
Population: The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in population (n = 33).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Surpass Flow Diverter (mITT Population) | 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. | Primary Effectiveness Endpoint Composite Success | 62.8 Percent of participants |
| Surpass Flow Diverter (mITT Population) | 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. | Parent Artery Stenosis > 50% | 3.3 Percent of participants |
| Surpass Flow Diverter (mITT Population) | 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. | Retreatment of Target Intracranial Aneurysm | 0.6 Percent of participants |
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.
Time frame: 12 months
Population: The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in arm (n = 33).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surpass Flow Diverter (mITT Population) | mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. | Major Ipsilateral Stroke | 19 Participants |
| Surpass Flow Diverter (mITT Population) | mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. | Neurological Death | 5 Participants |
| Surpass Flow Diverter (mITT Population) | mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. | Primary Safety Endpoint Failure | 19 Participants |
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).
Time frame: 12 months
Population: mITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surpass Flow Diverter (mITT Population) | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | Raymond-Roy I | 17 Participants |
| Surpass Flow Diverter (mITT Population) | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | Raymond-Roy II | 3 Participants |
| Surpass Flow Diverter (mITT Population) | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | Raymond-Roy III | 14 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | Raymond-Roy I | 99 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | Raymond-Roy II | 14 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | Raymond-Roy III | 12 Participants |
Other Pre-specified
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
Time frame: 12 Months
Population: mITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surpass Flow Diverter (mITT Population) | CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population | 107 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population | 6 Participants |
Other Pre-specified
Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up
Patients with minor strokes through 12 months
Time frame: 12 Months
Population: Secondary endpoint analysis of the mITT population (n = 180) are presented herein for comparison to results of subjects in the Roll-in population (n = 33).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surpass Flow Diverter (mITT Population) | Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up | 12 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up | 1 Participants |
Other Pre-specified
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
Time frame: 12 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surpass Flow Diverter (mITT Population) | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | None | 3 Participants |
| Surpass Flow Diverter (mITT Population) | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | One | 156 Participants |
| Surpass Flow Diverter (mITT Population) | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | Two | 21 Participants |
| Surpass Flow Diverter (mITT Population) | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | >2 | 0 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | >2 | 1 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | None | 0 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | Two | 7 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations | One | 25 Participants |
Post Hoc
Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up
Subjects experiencing neurologic death or disabling stroke through 12 months.
Time frame: 12 Months
Population: mITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Surpass Flow Diverter (mITT Population) | Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up | Disabling Stroke or Neurologic Death | 6.1 Percent of participants |
| Surpass Flow Diverter (mITT Population) | Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up | Neurologic Death | 2.8 Percent of participants |
| Surpass Flow Diverter (mITT Population) | Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up | Disabling Stroke | 6.1 Percent of participants |
Other Pre-specified
Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population
Primary effectiveness by age group
Time frame: 12 Months
Population: mITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surpass Flow Diverter (mITT Population) | Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population | 80 Participants |
| Device Fully Apposed to Vessel Wall at 12 Months | Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population | 33 Participants |