An Early Feasibility Study Assessing the Safety, Technical Performance, and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm, Intracranial
- Sponsor
- Evasc Medical Systems Corp.
- Primary Endpoint
- Serious Adverse Events following the eCLIPs procedure
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms. The eCLIPs device is a novel shield like implant that is placed across the neck of the aneurysm and not only facilitates coil retention but also partly obstructs the flow of blood into the aneurysm.
This is an early feasibility study, which is a small study investigating an innovative device to gather more clinical data before conducting a larger study. The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers. A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms.
Detailed Description
The primary objective of this study is to obtain preliminary confirmation that the eCLIPs Delivery Wire is safe and provides sufficient technical performance in delivering the eCLIPs Implant to distal tortuous anatomies. This study will be a multicentre, open label, single-arm safety, technical performance, and efficacy study of the Electrolytic eCLIPs Bifurcation System in the management of bifurcated intracranial aneurysms (IA). Subjects included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation, having a neck length of ≥ 4mm or have a dome:neck ratio \<2. Aside from the implantation of the eCLIPs Implant, the study will follow usual clinical care practices. The subjects will undergo clinical assessments at pre-discharge and 30 days, as well as clinical assessment and radiographic imaging at 6 and 12 months (Digital Subtraction Angiography; DSA). It is important to note that changes to the investigational device may occur during the course of this early feasibility study. Ongoing results of the study will be evaluated, along with collection of detailed operator feedback on usability, in order to determine whether further refinements to the eCLIPs Delivery Wire are required.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 with maximal diameter \<25mm and has a neck length of \> 4mm or dome:neck ratio \<2, arising at a bifurcation with branch artery diameters of 1.5mm to 3.25mm:
- •Patient understands the nature of the procedure and has the capacity to provide informed consent.
- •Patient is willing to have on-site follow-up evaluations up to 5-yrs
- •In the clinician's judgement, the aneurysm requires intervention, given risk of rupture or other rationale (as documented on the Screening CRF), and that the patient agrees with that clinician judgement
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 within 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 cardioembolic symptoms such as atrial fibrillation
- •Patient with any condition that, in the opinion of the treating physician, would place the subject 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.
- •Patient with resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other).
Outcomes
Primary Outcomes
Serious Adverse Events following the eCLIPs procedure
Time Frame: Within 30 days of the procedure
Proportion of subjects experiencing a device-related serious adverse event within 30 days following the procedure
Secondary Outcomes
- Technical Success(During Procedure)
- Success of adjuvant coiling(During Procedure)
- Aneurysm Occlusion(At 6 month and 12 month follow-up)
- Major ipsilateral stroke or neurologic death(Within12 months of procedure)
- All device-related adverse events (AEs)(Within 12 months of procedure)
- Deterioration in modified Rankin Scale (mRS) score at Follow up(30 days, 6, and 12 months following the procedure)
- Assessment of implant migration(6 and 12 months following procedure)
- Assessment of branch artery patency(6 and 12 months following procedure)
- Patient Outcomes - Hospitalization length of stay (LOS)(Within 12 months of procedure)
- Patient Outcomes - Subsequent hospitalization(Within 12 months of procedure)
- Patient Outcomes - Remedial actions required(Within 12 months of procedure)
- Patient Outcomes - Reintervention required(30 days, 6, and 12 months following the procedure)
- Patient Outcomes - Return to baseline or improved functioning(6 and 12 months following procedure)
- Patient Outcomes - Aneurysm recurrence(Within 30 days, 6, and 12 months following the procedure)
- Patient Outcomes - Aneurysm rupture(Within 30 days, 6, and 12 months following the procedure)
- Patient Outcomes - Neurologic deterioration(Immediate post-procedure prior to discharge)