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Intracranial AneurysmEESIS-FrNCT05330897

French eCLIPs™ Efficacy and Safety Investigation

A study testing Implantation of an eCLIPs™ device and eCLIPs™ Electrolytic Bifurcation Systems in people with Intracranial Aneurysm, run by Evasc Medical Systems Corp. at 28 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Implantation of an eCLIPs™ device and eCLIPs™ Electrolytic Bifurcation Systems
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
28 sitesFrance
Study dates
16 Dec 2021to 16 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 with a minimal diameter of 5mm and a maximal diameter <25mm, has a neck length of >4mm or dome:neck ratio <2, branch artery diameters in the range of 2.0mm to 3.25mm
  • Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
  • Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
  • Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice

Who cannot join

  • Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
  • 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) ≥ 1.5
  • 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
Show all 30Show fewer
  • 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 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 subject 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
  • Subject had a subarachnoid haemorrhage within 1 month prior to enrolment date
  • Subject has a non-treated arterio-venous malformation in the territory of the target aneurysm
  • Subject 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
  • Patient over the age of majority benefiting from legal protection (guardianship, curatorship, safeguard of justice)

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • CHU d'Amiens

    Amiens

  • Groupe Hospitalier Pellegrin

    Bordeaux

  • CHRU de Brest - Hôpital Cavale Blanche

    Brest

  • HCL - Hôpital Pierre Wertheimer

    Bron

  • CHU de Caen Normandie

    Caen

  • Hôpital Gabriel Montpied

    Clermont-Ferrand

  • CH de Colmar - Hôpital Louis Pasteur

    Colmar

  • Clinique des Cèdres

    Cornebarrieu

  • AP-HP - HU Henri-Mondor

    Créteil

  • Hôpital François Mitterrand

    Dijon

  • CHU Grenoble Alpes

    Grenoble

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • CHU de Limoges

    Limoges

  • Hôpital de La Timone

    Marseille

  • Hôpital privé Clairval

    Marseille

  • CHU de Montpellier - Hôpital Guy de Chauliac

    Montpellier

  • CHRU de Nancy - Hôpital Central

    Nancy

  • CHU de Nice - Hôpital Pasteur

    Nice

  • AP-HP - HU Pitié-Salpêtrière - Charles Foix

    Paris

  • CH Sainte-Anne

    Paris

  • Hôpital Fondation Adolphe de Rothschild

    Paris

  • CHU de Poitiers

    Poitiers

  • CHRU de Rennes -Hôpital Pontchaillou

    Rennes

  • CHU de Rouen

    Rouen

  • CHU de Nantes - Hôpital Laennec

    Saint-Herblain

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • CHI Toulon

    Toulon

  • CHRU de Tours - Bretonneau

    Tours

Other trials in France

About this study

Official title: A Multicentre Post Marketing Study in France Evaluating the Safety and Efficacy of the eCLIPs™ Family of Products for the Treatment of Bifurcation Intracranial Aneurysms at the Carotid and Basilar Terminus

The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.

Read the detailed description

This study is a multicentre, open label, historically controlled, single-arm safety and efficacy study of the eCLIPs™ products in the management of bifurcated intracranial aneurysms at basilar tip and carotid terminus. Patients with basilar tip and carotid terminus aneurysms are not considered suitable for surgical treatment by the neurovascular community because of the poor outcome in these localizations. Patients 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. Efficacy will be measured as the proportion of aneurysms achieving complete occlusion (Raymond-Roy 1) at 12 months, while safety will be measured as the proportion of patients without a major stroke or non-accidental death within 30 days (procedural) and without a major ipsilateral stroke or neurological death between 31 days and 12 months. Additional endpoints will be evaluated and data collected to assess safety and collect information on the eCLIPs™ family of products.

Being tested
Implantation of an eCLIPs™ device, eCLIPs™ Electrolytic Bifurcation Systems
Keywords
Bifurcation aneurysm, Basilar tip, Carotid terminus
Medical subject headings
Intracranial Aneurysm

What participants receive

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

  • Implantation of an eCLIPs™ deviceProcedure or surgery

    Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

  • eCLIPs™ Electrolytic Bifurcation SystemsDevice

    Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Study groups in NCT05330897
Study groupRoleWhat they receive
Treatment armExperimentalImplantation of an eCLIPs™ device
Receives: Procedure: Implantation of an eCLIPs™ device; Device: eCLIPs™ Electrolytic Bifurcation Systems

What is being measured

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

  1. Complete aneurysm occlusion with no recurrence or re-treatment

    Percent of subjects with complete aneurysm occlusion with no recurrence or re-treatment

    Measured: 12 months

  2. Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months

    Percent of subjects with a major stroke or non-accidental death within 30 days or with a major ipsilateral stroke or neurological death between 31 days and 12 months

    Measured: 12 months

Secondary outcomes (11)

  1. Technical success

    Proportion of successful eCLIPs™ device implants at the target aneurysm

    Measured: Immediately after the procedure

  2. Complete aneurysm occlusion

    Percent of subjects with complete aneurysm occlusion at 6 and 24 months

    Measured: 24 months

  3. Complete and nearly complete aneurysm occlusion

    Percent of subjects with complete and nearly complete aneurysm occlusion at 6, 12 and 24 months

    Measured: 24 months

  4. Major ipsilateral stroke or neurological death

    Percent of subjects with a major ipsilateral stroke or neurological death

    Measured: 24 months

  5. Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant

    Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs™ device, and the eCLIPs™ device to satisfactorily retain coils

    Measured: Immediately after the procedure

  6. Modified Rankin Score

    Percent of subjects experiencing deterioration of Rankin Score from baseline to 1 month, 6-month, 12-month, and 24-month follow-up

    Measured: 24 months

  7. Serious Adverse Device Effects

    Percent of subjects experiencing Serious Adverse Device Effects at 1, 6, 12 and 24 months

    Measured: 24 months

  8. Unplanned aneurysm re-treatment

    Percent of subjects having an unplanned aneurysm re-treatment within 12 or 24 months

    Measured: 24 months

  9. Device migration

    Proportion of device migration at 12 and 24 months

    Measured: 24 months

  10. Artery stenosis

    Measurement of artery stenosis by radiography at 6, 12 and 24 months

    Measured: 24 months

  11. Artery patency

    Qualitative assessment of artery patency at 6, 12 and 24 months

    Measured: 24 months

Timeline

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

  1. First posted15 Apr 2022
  2. Study start16 Dec 2021
  3. Primary completion16 Dec 2025 (estimated)
  4. Study completion16 Dec 2026 (estimated)

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
119 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05330897
Sponsor's protocol ID
CT-15-015
Acronym
EESIS-Fr
Status last verified
Aug 2025
First submitted
10 Mar 2022
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fiorella D, Arthur AS, Chiacchierini R, Emery E, Molyneux A, Pierot L. How safe and effective are existing treatments for wide-necked bifurcation aneurysms? Literature-based objective performance criteria for safety and effectiveness. J Neurointerv Surg. 2017 Dec;9(12):1197-1201. doi: 10.1136/neurintsurg-2017-013223. Epub 2017 Aug 10.

    PubMed 28798268

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of an eCLIPs™ device and eCLIPs™ Electrolytic Bifurcation Systems in people with Intracranial Aneurysm, run by Evasc Medical Systems Corp. at 28 sites in France.

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 5 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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?

Complete aneurysm occlusion with no recurrence or re-treatment (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05330897, which also lists 1 linked publication.

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 15 Aug 2025.

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