A Multi-center Post Marketing Study Evaluating the Safety, Technical Feasibility, and Efficacy of the eCLIPs™ Family of Products for the Treatment of Bifurcation Intracranial Aneurysms.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Saccular Aneurysm
- Sponsor
- Evasc Medical Systems Corp.
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Safety End Point: absence of a major territorial stroke or death (procedural).
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient whose age is greater than 18 years old
- •Patient with an unruptured or previously ruptured (at least 1 month from date of rupture and with partial occlusion of the dome of the aneurysm by endovascular techniques or by open neurosurgery, and in stable neurological condition-WFNS I and II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus and has a neck length of \> 4mm or dome:neck ratio \<
- •Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 1.5mm and 3.25mm
- •Patient understands the nature of the procedure and has the capacity to provide informed consent.
- •Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice.
Exclusion Criteria
- •Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- •Major surgery within previous 30 days or planned in the next 120 days after enrolment.
- •Patient with an International Normalized Ratio (INR)≥ 1.
- •Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment.
- •Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
- •Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
- •Patient with any condition that, in the opinion of the treating physician, would place the participant at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, blood disorders).
- •Patient with known allergies to nickel-titanium metal
- •Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia.
- •Subject has resistance to Prasugrel based on a validated platelet testing method (Verify Now, Multiplate or other).
Outcomes
Primary Outcomes
Safety End Point: absence of a major territorial stroke or death (procedural).
Time Frame: 30 days
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.
Absence of a major territorial stroke or neurological death
Time Frame: 31 days to 12 months
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.
Complete aneurysm occlusion (Raymond 1 )
Time Frame: 12 months
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.
Secondary Outcomes
- eCLIPs Bifurcation Remodeling System Technical Success(Procedural)
- Complete or near complete (Raymond 1 and 2)(6 and 12 months)
- Degree of Flow Diversion (reduction of blood flow into aneurysm)(immediately after eCLIPs implant, before coiling)
- Success of adjuvant coiling into aneurysm after successful eCLIPs Device implant(Procedural)
- Change in Modified Rankin Score(from Baseline to 1 month, 6 months and 12 months)
- Occurrence of unplanned aneurysm re-treatment(within 12 months)
- Assessment of Device Migration(at 6 months and 12 months)
- Assessment of artery stenosis at the device location(at 6 months and 12 months)
- Assessment of artery patency at the target aneurysm(at 6 months and 12 months)