Status:
ACTIVE_NOT_RECRUITING
French eCLIPs™ Efficacy and Safety Investigation
Lead Sponsor:
Evasc Medical Systems Corp.
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2026
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05330897
Start Date
December 16 2021
End Date
December 16 2026
Last Update
August 15 2025
Active Locations (28)
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1
CHU d'Amiens
Amiens, France
2
Groupe Hospitalier Pellegrin
Bordeaux, France
3
CHRU de Brest - Hôpital Cavale Blanche
Brest, France
4
HCL - Hôpital Pierre Wertheimer
Bron, France