aneurysm bulge
Conditions
Interventions
None listed
Sponsors
Evasc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient whose age is greater than 18 years old 2. Patient with an unruptured or previously ruptured (at least 1 months 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 and has a neck length of > 4mm or dome:neck ratio
Exclusion criteria
Exclusion criteria: 1. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region. 2. Major surgery within previous 30 days or planned in the next 120 days after enrolment. 3. Patient with an International Normalized Ratio (INR)>= 1.5. 4. Patient with serum creatinine level >=104 µmol/L (or 2.5mg/dL) at time of enrolment. 5. Patient with a platelet count *100x103 cells/mm3 or known platelet dysfunction at time of enrolment 6. Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation 7. 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). 8. Patient with known allergies to nickel-titanium metal 9. Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia. 10. Subject has resistance to Prasugrel based on a validated platelet testing method (Verify Now, Multiplate or other). 11. Patient with a life threatening allergy to contrast (unless treatment for allergy is tolerated). 12. Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy. 13. Patient who is currently participating in another clinical research study involving an investigational product. 14. 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 15. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to the treatment date. 16. More than one intracranial aneurysm that requires treatment within 12 months. 17. Asymptomatic extradural aneurysms requiring treatment. 18. Severe neurological deficit that renders the subject incapable of living independently. 19. Unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days. 20. Dementia or psychiatric problem that prevents the subject from completing required follow up. 21. Subject had a subarachnoid haemorrhage within 6 months prior to enrolment date. 22. Subject has a non-treated arterio-venous malformation in the territory of the target aneurysm. 23. Subject has a need for long-term use of anticoagulants. 24. Patient who is unable to complete the required follow-up. 25. Inability to understand the study or history of non-compliance with medical advice. 26. Evidence of active infection at the time of treatment. 27. Patient who is pregnant or breastfeeding. 28. Patient who has participated in a drug study within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety End Point: absence of a major territorial stroke or death within 30 days (procedural). 2. Safety End Point: absence of a major territorial stroke or neurological death between 31 days and 12 months 3. Efficacy End Point: complete aneurysm occlusion (Raymond 1 ) at 6 months 4. Efficacy End Point: complete aneurysm occlusion (Raymond 1 ) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. eCLIPs Bifurcation Remodeling System Technical Success: measured by the proportion of successful eCLIPs Device implants at the target aneurysm. 2. Efficacy End Point: complete or near complete (Raymond 1 and 2) at 6 months and 12 months 3. Degree of Flow Diversion (reduction of blood flow into aneurysm) immediately after successful eCLIPs Device implant. 4. Success of adjuvant coiling into aneurysm after successful eCLIPs Device implant 5. Change in Modified Rankin Score from Baseline to 1, 6, and 12 Month Follow-up 6. Occurrence of unplanned aneurysm re-treatment within 12 months (endovascular or surgical repair) 7. Assessment of Device Migration at 6 months and 12 months 8. Assessment of artery stenosis at the device location at 6 months and 12 months 9. Assessment of artery patency at the target aneurysm at 6 months and 12 months | — |
Countries
Netherlands
Outcome results
None listed