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Aneurysm, IntracranialNCT04886505

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

A study testing Electrolytic eCLIPs Bifurcation System in people with Aneurysm, Intracranial, run by Evasc Medical Systems Corp..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Aneurysm, Intracranial
What is being tested?
Electrolytic eCLIPs Bifurcation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.
  • More than one intracranial aneurysm that requires treatment within 12 months.
  • Asymptomatic extradural aneurysms requiring treatment.
  • Severe neurological deficit that renders the patient incapable of living independently.
  • Unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days.
  • Dementia or psychiatric problem that prevents the subject from completing required follow up.
  • Patient had a subarachnoid haemorrhage within 1 month prior to enrolment date.
  • Patient has a non-treated arterio-venous malformation in the territory of the target aneurysm.
  • Patient has a need for long-term use of anticoagulants.
  • Patient who is unable to complete the required follow-up.
  • Inability to understand the study or history of non-compliance with medical advice.
  • Evidence of active infection at the time of treatment.
  • Patient who is pregnant or breastfeeding.
  • Patient who has participated in a drug study within the last 30 days.

About this study

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

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.

Read the 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.

Being tested
Electrolytic eCLIPs Bifurcation System
Keywords
Bifurcation aneurysm, Coil retention, Flow diversion
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrolytic eCLIPs Bifurcation SystemDevice

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

Study groups in NCT04886505
Study groupRoleWhat they receive
TreatmentExperimentalSingle arm study - treatment with Electrolytic eCLIPs Bifurcation System
Receives: Device: Electrolytic eCLIPs Bifurcation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events following the eCLIPs procedure

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

    Measured: Within 30 days of the procedure

Secondary outcomes (16)

  1. Technical Success

    Proportion of subjects with procedural success for the Electrolytic eCLIPs Bifurcation System. Procedural success defined as: access to the aneurysm, successful deployment, implantation of the eCLIPs Implant, and successful neck bridging of the target aneurysm, as judged by core lab evaluation of the procedural angiogram.

    Measured: During Procedure

  2. Success of adjuvant coiling

    Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs Implant, and the eCLIPs Implant to satisfactorily retain coils; irrespective of coil density or degree of occlusion.

    Measured: During Procedure

  3. Aneurysm Occlusion

    Proportion of subjects with successful aneurysm treatment with the eCLIPs Implant and embolic coils, as measured by aneurysm occlusion of Modified Raymond-Roy Classification of 1 (no aneurysmal opacification) or 2 (residual neck) using DSA

    Measured: At 6 month and 12 month follow-up

  4. Major ipsilateral stroke or neurologic death

    Proportion of subjects experiencing major stroke of neurologic death within 30 days, 6 and 12 months following the procedure.

    Measured: Within12 months of procedure

  5. All device-related adverse events (AEs)

    A quantitative and descriptive summary of all device-related AEs experienced within 30 days, 6 and 12 months following the procedure.

    Measured: Within 12 months of procedure

  6. Deterioration in modified Rankin Scale (mRS) score at Follow up

    Proportion of subjects experiencing deterioration of modified Rankin Scale (mRS) score from baseline to 30 days, 6 and 12 month follow-up. Neurologic evaluation must be performed by independent qualified personnel.

    Measured: 30 days, 6, and 12 months following the procedure

  7. Assessment of implant migration

    Proportion of subjects with implant migration at 6 and 12 months follow up. Migration is defined as movement of the eCLIPs implant by 5mm compared to the position at implantation per core lab evaluation.

    Measured: 6 and 12 months following procedure

  8. Assessment of branch artery patency

    Proportion of subjects whose branch arteries (of the target aneurysm) are patent at 6 and 12 month follow up per core lab evaluation.

    Measured: 6 and 12 months following procedure

  9. Patient Outcomes - Hospitalization length of stay (LOS)

    Mean hospitalization LOS for index procedure.

    Measured: Within 12 months of procedure

  10. Patient Outcomes - Subsequent hospitalization

    Proportion of subjects requiring any subsequent hospitalization related to the index aneurysm.

    Measured: Within 12 months of procedure

  11. Patient Outcomes - Remedial actions required

    Proportion of subjects requiring remedial action for an adverse event during index procedure.

    Measured: Within 12 months of procedure

  12. Patient Outcomes - Reintervention required

    Proportion of subjects with complications, neurologic deterioration or adverse events requiring reintervention.

    Measured: 30 days, 6, and 12 months following the procedure

  13. Patient Outcomes - Return to baseline or improved functioning

    Proportion of subjects returning to baseline functioning or improved functioning as measured by modified Rankin Scale (mRS). Baseline mRS compared to mRS at follow up.

    Measured: 6 and 12 months following procedure

  14. Patient Outcomes - Aneurysm recurrence

    Proportion of subjects with index aneurysm recurrence.

    Measured: Within 30 days, 6, and 12 months following the procedure

  15. Patient Outcomes - Aneurysm rupture

    Proportion of subjects with index aneurysm rupture.

    Measured: Within 30 days, 6, and 12 months following the procedure

  16. Patient Outcomes - Neurologic deterioration

    Proportion of subjects with neurologic deterioration pre-discharge.

    Measured: Immediate post-procedure prior to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion1 Sep 2023 (estimated)

Why it stopped: Insufficient funds

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04886505
Sponsor's protocol ID
CS 20-018
Status last verified
Sep 2021
First submitted
10 May 2021
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Electrolytic eCLIPs Bifurcation System in people with Aneurysm, Intracranial, run by Evasc Medical Systems Corp..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events following the eCLIPs procedure (time frame: Within 30 days of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04886505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.

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