Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT04886505
Eligibility Criteria:
Inclusion Criteria:
1. 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 with maximal diameter \<25mm and has a neck length of \> 4mm or dome:neck ratio \<2, arising at a bifurcation with branch artery diameters of 1.5mm to 3.25mm:
2. Patient understands the nature of the procedure and has the capacity to provide informed consent.
3. Patient is willing to have on-site follow-up evaluations up to 5-yrs
4. In the clinician's judgement, the aneurysm requires intervention, given risk of rupture or other rationale (as documented on the Screening CRF), and that the patient agrees with that clinician judgement
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 within 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 cardioembolic symptoms such as atrial fibrillation
7. Patient with any condition that, in the opinion of the treating physician, would place the subject 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. Patient with resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other).
11. 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).
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 patient 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. Patient had a subarachnoid haemorrhage within 1 month prior to enrolment date.
22. Patient has a non-treated arterio-venous malformation in the territory of the target aneurysm.
23. Patient 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04886505
Study Brief:
Protocol Section:
NCT04886505