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

NCT04886505 | Withdrawn DMC FDA Device

• 1 other identifier: CS 20-018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aneurysm, Intracranial

Keywords

Bifurcation aneurysm; Coil retention; Flow diversion

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events following the eCLIPs procedure

  Proportion of subjects experiencing a device-related serious adverse event within 30 days following the procedure

  Within 30 days of the procedure

Secondary Outcomes (16)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Single arm study - treatment with Electrolytic eCLIPs Bifurcation System

Device: Electrolytic eCLIPs Bifurcation System

Interventions

Electrolytic eCLIPs Bifurcation System DEVICE

The electrolytic eCLIPs bifurcation system will be implanted into patients with bifurcated saccular intra-cranial aneurysms.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)≥ 1.5.
• 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).
• Patient with a life-threatening allergy to contrast (patients with itching or rash as a reaction to contrast can be included if properly prophylactically treated).
• Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
• Patient who is currently participating in another clinical research study involving an investigational product.
• Patient who has had a previous intracranial procedure associated with the target aneurysm such that access and placement of an eCLIPS device would be compromised
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to the treatment date.

Sponsors & Collaborators

• Evasc Medical Systems Corp.: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: January 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share