French ECLIPs™ Efficacy and Safety Investigation

Last updated: September 12, 2024
Sponsor: Evasc Medical Systems Corp.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

eCLIPs™ Electrolytic Bifurcation Systems

Implantation of an eCLIPs™ device

Clinical Study ID

NCT05330897
CT-15-015
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient whose age is greater than 18 years old

  2. Patient with an unruptured or previously ruptured (at least 1 month from date ofrupture and with partial occlusion of the dome of the aneurysm by endovasculartechniques or by open neurosurgery, and in stable neurological condition-WFNS I andII with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm orrecurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminuswith 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

  3. Patient aneurysm arises at a bifurcation artery with at least one of the two branchartery vessels having a diameter between 2.0mm and 3.25mm

  4. Patient understands the nature of the procedure and has the capacity to provideinformed consent (including fluency in French language)

  5. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-upevaluations as per standard clinical practice

Exclusion

Exclusion Criteria:

  1. Patient with an aneurysm deemed to be an eligible candidate for surgical clipping bythe investigator

  2. Patient who presents with an intracranial mass or currently undergoing radiationtherapy for carcinoma of the head or neck region

  3. Major surgery within previous 30 days or planned in the next 120 days afterenrolment

  4. Patient with an International Normalized Ratio (INR) ≥ 1.5

  5. Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment

  6. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction attime of enrolment

  7. Patient who has a known cardiac disorder, likely to be associated withcardio-embolic symptoms such as atrial fibrillation

  8. Patient with any condition that, in the opinion of the treating physician, wouldplace the participant at a high risk of embolic stroke or with any medicalco-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolleddiabetes, blood disorders)

  9. Patient with known allergies to nickel-titanium metal

  10. Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel,prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia

  11. Subject has resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other)

  12. Patient with a life threatening allergy to contrast (patients with itching or rashas a reaction to contrast can be included if properly prophylactically treated)

  13. Patient with inappropriate anatomy as demonstrated by angiography due to severeintracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsiveto medical therapy

  14. Patient who is currently participating in another clinical research study involvingan investigational product

  15. Patient who has had a previous intracranial procedure associated with the targetaneurysm such that access and placement of an eCLIPs™ device would be compromised

  16. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebralartery) or intracranial artery within 30 days prior to the treatment date

  17. More than one intracranial aneurysm that requires treatment within 12 months.

  18. Asymptomatic extradural aneurysms requiring treatment

  19. Severe neurological deficit that renders the subject incapable of livingindependently

  20. Unstable neurological deficit (i.e. worsening or improvement of clinical conditionin the last 30 days

  21. Dementia or psychiatric problem that prevents the subject from completing requiredfollow up

  22. Subject had a subarachnoid haemorrhage within 1 month prior to enrolment date

  23. Subject has a non-treated arterio-venous malformation in the territory of the targetaneurysm

  24. Subject has a need for long-term use of anticoagulants

  25. Patient who is unable to complete the required follow-up

  26. Inability to understand the study or history of non-compliance with medical advice

  27. Evidence of active infection at the time of treatment

  28. Patient who is pregnant or breastfeeding

  29. Patient who has participated in a drug study within the last 30 days

  30. Patient over the age of majority benefiting from legal protection (guardianship,curatorship, safeguard of justice)

Study Design

Total Participants: 119
Treatment Group(s): 2
Primary Treatment: eCLIPs™ Electrolytic Bifurcation Systems
Phase:
Study Start date:
December 16, 2021
Estimated Completion Date:
April 16, 2026

Study 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.

Connect with a study center

  • CHU d'Amiens

    Amiens,
    France

    Active - Recruiting

  • Groupe Hospitalier Pellegrin

    Bordeaux,
    France

    Active - Recruiting

  • CHRU de Brest - Hôpital Cavale Blanche

    Brest,
    France

    Active - Recruiting

  • HCL - Hôpital Pierre Wertheimer

    Bron,
    France

    Active - Recruiting

  • CHU de Caen Normandie

    Caen,
    France

    Active - Recruiting

  • Hôpital Gabriel Montpied

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CH de Colmar - Hôpital Louis Pasteur

    Colmar,
    France

    Active - Recruiting

  • Clinique des Cèdres

    Cornebarrieu,
    France

    Active - Recruiting

  • AP-HP - HU Henri-Mondor

    Créteil,
    France

    Active - Recruiting

  • Hôpital François Mitterrand

    Dijon,
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    Grenoble,
    France

    Active - Recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre,
    France

    Active - Recruiting

  • CHU de Limoges

    Limoges,
    France

    Active - Recruiting

  • Hôpital de La Timone

    Marseille,
    France

    Active - Recruiting

  • Hôpital privé Clairval

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier - Hôpital Guy de Chauliac

    Montpellier,
    France

    Active - Recruiting

  • CHRU de Nancy - Hôpital Central

    Nancy,
    France

    Active - Recruiting

  • CHU de Nice - Hôpital Pasteur

    Nice,
    France

    Active - Recruiting

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

    Paris,
    France

    Active - Recruiting

  • CH Sainte-Anne

    Paris,
    France

    Active - Recruiting

  • Hôpital Fondation Adolphe de Rothschild

    Paris,
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CHRU de Rennes -Hôpital Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

  • CHU de Nantes - Hôpital Laennec

    Saint-Herblain,
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • CHI Toulon

    Toulon,
    France

    Active - Recruiting

  • CHRU de Tours - Bretonneau

    Tours,
    France

    Active - Recruiting

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