Intracranial Aneurysm
Conditions
Keywords
Bifurcation aneurysm, Basilar tip, Carotid terminus
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 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.
Interventions
PROCEDUREImplantation of an eCLIPs™ device
Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm
DEVICEeCLIPs™ Electrolytic Bifurcation Systems
Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm
Sponsors
European Cardiovascular Research Center
Evasc Medical Systems Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete aneurysm occlusion with no recurrence or re-treatment | 12 months | Percent of subjects with complete aneurysm occlusion with no recurrence or re-treatment |
| Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months | 12 months | Percent of subjects with a major stroke or non-accidental death within 30 days or with a major ipsilateral stroke or neurological death between 31 days and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete and nearly complete aneurysm occlusion | 24 months | Percent of subjects with complete and nearly complete aneurysm occlusion at 6, 12 and 24 months |
| Major ipsilateral stroke or neurological death | 24 months | Percent of subjects with a major ipsilateral stroke or neurological death |
| Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant | Immediately after the procedure | Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs™ device, and the eCLIPs™ device to satisfactorily retain coils |
| Modified Rankin Score | 24 months | Percent of subjects experiencing deterioration of Rankin Score from baseline to 1 month, 6-month, 12-month, and 24-month follow-up |
| Technical success | Immediately after the procedure | Proportion of successful eCLIPs™ device implants at the target aneurysm |
| Unplanned aneurysm re-treatment | 24 months | Percent of subjects having an unplanned aneurysm re-treatment within 12 or 24 months |
| Device migration | 24 months | Proportion of device migration at 12 and 24 months |
| Artery stenosis | 24 months | Measurement of artery stenosis by radiography at 6, 12 and 24 months |
| Artery patency | 24 months | Qualitative assessment of artery patency at 6, 12 and 24 months |
| Serious Adverse Device Effects | 24 months | Percent of subjects experiencing Serious Adverse Device Effects at 1, 6, 12 and 24 months |
| Complete aneurysm occlusion | 24 months | Percent of subjects with complete aneurysm occlusion at 6 and 24 months |
Countries
France
Outcome results
None listed