An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms

An Early Feasibility Study Assessing the Safety, Technical Performance, and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms

NCT04886505•Evasc Medical Systems Corp.

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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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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:
•2. Patient understands the nature of the procedure and has the capacity to provide informed consent.
•3. Patient is willing to have on-site follow-up evaluations up to 5-yrs
•4. 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

•1. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
•2. Major surgery within previous 30 days or planned within 120 days after enrolment.
•3. Patient with an International Normalized Ratio (INR)≥ 1.5.
•4. Patient with serum creatinine level ≥104 μmol/L (or 2.5mg/dL) at time of enrolment.
•5. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
•6. Patient who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as atrial fibrillation
•7. 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).
•8. Patient with known allergies to nickel-titanium metal
•9. Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia.
•10. Patient with resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other).
+18 more criteria

Key Dates

Start Date

January 1, 2022

Primary Completion Date

September 30, 2022

Completion Date

September 1, 2023

Last Updated

April 18, 2022

Conditions

Aneurysm, Intracranial

Interventions

Electrolytic eCLIPs Bifurcation System

DEVICE

US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

NCT04852783

Aneurysm, Intracranial

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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