An open label, prospective, multicentre, single-arm, post marketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms.
The objective of this study is to obtain data on the technical feasibility, safety, and efficacy of the eCLIPs™ Products for the treatment of bifurcation aneurysms. Specifically, procedural success of the eCLIPs Bifurcation Remodelling System (BRS) will be evaluated to determine feasibility of this product and safety will be measured as of a major stroke or death within 30 days, or major territorial stroke or neurological death within one year. Additional endpoints will be evaluated and data collected to assess the procedural success of the other eCLIPs Products Microcatheter, Microintroducer, Detacher) and collect efficacy information on the eCLIPs Products. A rate of 69% of aneurysms achieving Raymond Class 1 occlusion at the 12 month endpoint has been chosen as the criterion for success in subjects treated with the eCLIPs Device and coils (primary endpoint). An upper 95% confidence interval of 10% rate of major ipsilateral stroke or death at the 1 month, and 12 month endpoint has been chosen to demonstrate clinically safety (primary endpoint).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implant eCLIPs at target bifurcation aneurysm
Aarhus Universitetshospital
Aarhus, Denmark
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
Maastricht University Hospital
Maastricht, Netherlands
Radboudumc
Nijmegen, Netherlands
Safety End Point: absence of a major territorial stroke or death (procedural).
Major territorial stroke was defined as an ischemic or hemorrhagic stroke resulting in an increase of ≥4 points on the NIH Stroke Scale/Score (NIHSS) and that persisted for \>24 hours. NIHSS ranges from 0 to 4; with lower scores indicating better outcome.
Time frame: 30 days
Absence of a major territorial stroke or neurological death
Major territorial stroke was defined as an ischemic or hemorrhagic stroke resulting in an increase of ≥4 points on the NIH Stroke Scale/Score (NIHSS) and that persisted for \>24 hours. NIHSS ranges from 0 to 4; with lower scores indicating better outcome.
Time frame: 31 days to 12 months
Complete aneurysm occlusion (Raymond 1 )
complete aneurysm occlusion (modified Raymond-Roy classification (mRRc) I), adjudicated by an independent core laboratory. mRRC ranges from 1 to 3b; where lower scores (1) indicate better outcome.
Time frame: 6 months
Complete aneurysm occlusion (Raymond 1 )
complete aneurysm occlusion (modified Raymond-Roy classification (mRRc) I), adjudicated by an independent core laboratory. mRRC ranges from 1 to 3b; where lower scores (1) indicate better outcome.
Time frame: 12 months
eCLIPs Bifurcation Remodeling System Technical Success
measured by the proportion of successful eCLIPs Device implants at the target aneurysm
Time frame: Procedural
Complete or near complete (Raymond 1 and 2)
complete aneurysm occlusion (modified Raymond-Roy classification (mRRc) I or II), adjudicated by an independent core laboratory. mRRC ranges from 1 to 3b; where lower scores (1) indicate better outcome.
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Time frame: 6 and 12 months
Degree of Flow Diversion (reduction of blood flow into aneurysm)
reduction of blood flow into aneurysm according to the O'Kelly-Marotta (OKM) grading scale
Time frame: immediately after eCLIPs implant, before coiling
Success of adjuvant coiling into aneurysm after successful eCLIPs Device implant
Success of adjunctive coiling into aneurysm after successful eCLIPs implantation, assessed by the operator.
Time frame: Procedural
Change in Modified Rankin Score
Change in Modified Rankin Score (mRS) from baseline. The mRS ranges from 0 to 6; lower scores indicate better outcome.
Time frame: from Baseline to 1 month, 6 months and 12 months
Occurrence of unplanned aneurysm re-treatment
endovascular or surgical repair
Time frame: within 12 months
Assessment of Device Migration
Frequency of eCLIPs Device migration
Time frame: at 6 months and 12 months
Assessment of artery stenosis at the device location
Frequency of cases with artery stenosis at the device location
Time frame: at 6 months and 12 months
Assessment of artery patency at the target aneurysm
Frequency of cases with artery patency at the target aneurysm
Time frame: at 6 months and 12 months