French ECLIPs™ Efficacy and Safety Investigation

Launched by EVASC MEDICAL SYSTEMS CORP. · Apr 10, 2022

Keywords

ClinConnect Summary

The French ECLIPs™ study is looking at a new treatment option for people with intracranial aneurysms, specifically those that occur at the branching points of blood vessels in the brain, known as bifurcation aneurysms. The goal is to see how safe and effective the eCLIPs™ products are in treating these aneurysms. If you are over 18 and have a specific type of aneurysm that meets certain size and shape criteria, you might be eligible to participate in this trial. It's important that participants can understand the study and provide consent, and they must be willing to attend follow-up appointments at 30 days, 6 months, and 12 months after the procedure.

If you join the trial, you will receive treatment with the eCLIPs™ device, and your health will be monitored closely to ensure your safety and the effectiveness of the treatment. However, there are some conditions that would exclude you from participating, such as having certain medical issues or being involved in other clinical studies. Overall, this trial could help improve future treatments for aneurysms, making it a potentially important opportunity for eligible patients.

Gender

ALL

Eligibility criteria

• 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 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
• • 3. 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
• • 4. Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
• • 5. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice
• Exclusion Criteria:
• • 1. Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
• • 2. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
• • 3. Major surgery within previous 30 days or planned in the next 120 days after enrolment
• • 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 at time of enrolment
• • 7. Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
• • 8. 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)
• • 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 rash as a reaction to contrast can be included if properly prophylactically treated)
• • 13. Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy
• • 14. Patient who is currently participating in another clinical research study involving an investigational product
• • 15. 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
• • 16. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) 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 living independently
• • 20. Unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days
• • 21. Dementia or psychiatric problem that prevents the subject from completing required follow 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 target aneurysm
• • 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)