Phase
Condition
Aneurysm
Treatment
eCLIPs™ Electrolytic Bifurcation Systems
Implantation of an eCLIPs™ device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient whose age is greater than 18 years old
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
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
Patient understands the nature of the procedure and has the capacity to provideinformed consent (including fluency in French language)
Patient is willing to have on-site 30- day, 6-month, and 12 month follow-upevaluations as per standard clinical practice
Exclusion
Exclusion Criteria:
Patient with an aneurysm deemed to be an eligible candidate for surgical clipping bythe investigator
Patient who presents with an intracranial mass or currently undergoing radiationtherapy for carcinoma of the head or neck region
Major surgery within previous 30 days or planned in the next 120 days afterenrolment
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 attime of enrolment
Patient who has a known cardiac disorder, likely to be associated withcardio-embolic symptoms such as atrial fibrillation
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)
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 rashas a reaction to contrast can be included if properly prophylactically treated)
Patient with inappropriate anatomy as demonstrated by angiography due to severeintracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsiveto medical therapy
Patient who is currently participating in another clinical research study involvingan investigational product
Patient who has had a previous intracranial procedure associated with the targetaneurysm such that access and placement of an eCLIPs™ device would be compromised
Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebralartery) 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 livingindependently
Unstable neurological deficit (i.e. worsening or improvement of clinical conditionin the last 30 days
Dementia or psychiatric problem that prevents the subject from completing requiredfollow 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 targetaneurysm
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)
Study Design
Study Description
Connect with a study center
CHU d'Amiens
Amiens,
FranceActive - Recruiting
Groupe Hospitalier Pellegrin
Bordeaux,
FranceActive - Recruiting
CHRU de Brest - Hôpital Cavale Blanche
Brest,
FranceActive - Recruiting
HCL - Hôpital Pierre Wertheimer
Bron,
FranceActive - Recruiting
CHU de Caen Normandie
Caen,
FranceActive - Recruiting
Hôpital Gabriel Montpied
Clermont-Ferrand,
FranceActive - Recruiting
CH de Colmar - Hôpital Louis Pasteur
Colmar,
FranceActive - Recruiting
Clinique des Cèdres
Cornebarrieu,
FranceActive - Recruiting
AP-HP - HU Henri-Mondor
Créteil,
FranceActive - Recruiting
Hôpital François Mitterrand
Dijon,
FranceActive - Recruiting
CHU Grenoble Alpes
Grenoble,
FranceActive - Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre,
FranceActive - Recruiting
CHU de Limoges
Limoges,
FranceActive - Recruiting
Hôpital de La Timone
Marseille,
FranceActive - Recruiting
Hôpital privé Clairval
Marseille,
FranceActive - Recruiting
CHU de Montpellier - Hôpital Guy de Chauliac
Montpellier,
FranceActive - Recruiting
CHRU de Nancy - Hôpital Central
Nancy,
FranceActive - Recruiting
CHU de Nice - Hôpital Pasteur
Nice,
FranceActive - Recruiting
AP-HP - HU Pitié-Salpêtrière - Charles Foix
Paris,
FranceActive - Recruiting
CH Sainte-Anne
Paris,
FranceActive - Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris,
FranceActive - Recruiting
CHU de Poitiers
Poitiers,
FranceActive - Recruiting
CHRU de Rennes -Hôpital Pontchaillou
Rennes,
FranceActive - Recruiting
CHU de Rouen
Rouen,
FranceActive - Recruiting
CHU de Nantes - Hôpital Laennec
Saint-Herblain,
FranceActive - Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg,
FranceActive - Recruiting
CHI Toulon
Toulon,
FranceActive - Recruiting
CHRU de Tours - Bretonneau
Tours,
FranceActive - Recruiting
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