|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P170024 / PAS001 |
| Date Original Protocol Accepted |
07/13/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
SCENT Post-Approval Study
|
| Device Name |
Surpass Streamline Flow Diverter
|
| Clinical Trial Number(s) |
NCT01716117
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the trial is to determine the long-term safety and effectiveness of the Surpass Flow Diverter in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus.
|
| Study Population |
Subjects with a large or giant intracranial aneurysm in the internal carotid artery up to the terminus
|
| Sample Size |
213 Subjects Enrolled
|
| Key Study Endpoints |
The primary efficacy endpoint as determined by the angiographic core lab, is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as = 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment at the target aneurysm at the 12 month follow-up visit. Safety success is achieved with a primary safety event rate significantly less than 20%
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
236 subjects were enrolled in the SCENT Post-Approval Study; 213 subjects (90.3%) received treatment and 23 subjects (9.7%) were Enrolled but not Treated (ENT). Of the 213 subjects who completed the study procedure, 180 comprise the modified Intent to Treat (mITT) cohort and 33 comprise the Roll-in cohort.
|
| Actual Number of Sites Enrolled |
26 sites, including 25 US sites and 1 international site
|
| Patient Follow-up Rate |
The follow-up rates for mITT cohort at 1-yr, 2-yr, 3-yr, 4-yr, and 5-yr follow-up visits are 96.5%, 97.6%, 89.9%, 97.9% and 96.7% respectively.
The follow-up rates for Roll-in cohort at 1-yr, 2-yr, 3-yr, 4-yr, and 5-yr follow-up visits are 100%, 100%, 89.3%, 100% and 100% respectively.
|
| Final Safety Findings |
Summary of primary safety and efficacy endpoints at 12 months follow-up
The primary safety endpoint is the rate of neurological death or major ipsilateral stroke through 12-months. The primary safety rate in the SCENT Post-Approval Study mITT population was 11.1% [95% CI of (6.92% - 16.64%)], with the upper limit being less than the performance goal of 20%, rejecting the null hypothesis at p = 0.001.
The primary efficacy endpoint is 100% target intracranial aneurysm occlusion (Raymond Class 1) without clinically significant stenosis (defined as = 50% stenosis of the parent artery) of the parent artery based on core lab evaluation at 12-months follow up angiogram and without any subsequent treatment at the target intracranial aneurysm at the 12-months follow up visit. The primary effectiveness rate in the SCENT Post-Approval Study mITT population was 62.8% [95% CI of (55.3% - 69.9%)], rejecting the null hypothesis at p = 0.001.
Summary of long-term safety and efficacy endpoints for 12-60 months follow-up
Description of the mITT cohort:
Neurological Death: N=5, no change from the 12-months follow-up during the long-term follow-up; note, subject 28-007 died of a neurological death at 1849 days post-procedure, which is outside of the 5-year follow-up cut-off date which was defined as 1825 days.
Clinical Events Committee (CEC) Adjudicated new or worsening major ipsilateral stroke: 11.1% (20/180) at 12-months and 21, 22, 23, and 23 subjects at 24, 36, 48, and 60 months respectively.
Aneurysm Rupture: four subjects (2.2%; 4/180) at 12-month; no change from the 12-months follow-up during the long-term follow-up.
Incidence of retreatment: 0.6% (1/180) at 12-months, 1.1% (2/180) at 24 months, and 2.8% (5/180) at 36 months. No additional retreatment occurred through 60 months.
Unchanged or improved functional outcome scores (as measured by modified Rankin Scale (mRS) score compared to baseline): 82.8% (111/134) at 36 months and 80.7% (96/119) at 60 months.
Worsening in mRS: 10.0% (18/180) at 12-months timepoint; at 36-months, the rate of change compared to baseline was 10.4% (14/134); at 60-months, the rate of change was 9.2% (11/119).
Description of the Roll-in cohort:
Neurological Death: N=3, per CEC adjudication, 1 neurological death was reported at 12 months, 1 neurological death occurred at 36 months, and 1 additional neurological death occurred at 60 months. No change in the number of neurological death since the last report.
CEC Adjudicated new or worsening major ipsilateral stroke: 4, 4, 4, 5, and 5 at 12, 24, 36, 48 and 60 months, respectively.
Aneurysm Rupture: No subject (0/0) in the Roll-In cohort experienced aneurysm rupture at any long-term follow-up time point.
Incidence of retreatment: 0, 0, 1, 1, 1 at 12, 24, 36, 48 and 60 months, respectively.
Unchanged or improved functional outcome scores (as measured by mRS compared to baseline): 88.0% (22/25) at 36 months and 85.7% (18/21) at 60 months, compared to the 78.8% (26/33) measured at 12-months.
Worsening in mRS: at 12-months timepoint was 15.2% (5/33); at 36 months, the rate of worsening was (8%; 2/25); at 60 months, the rate of change was 9.5% (2/21).
|
| Study Strengths & Weaknesses |
Strength: A prospective and long-term study with follow-up rate for mITT and Roll-in cohorts at about 90%.
Weaknesses: Single-arm study not controlling for confounding factors. Gender distribution is skewed. The majority of study subjects were female (91.1%) and male subjects were under represented, which leads to a limitation in the generalizability of the study results.
|
| Recommendations for Labeling Changes |
yes
|
