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:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT04548856
Eligibility Criteria:
Inclusion Criteria:
* Patients with ruptured (acute SAH) or unruptured cerebral aneurysm who require surgical treatment (clipping and / or embolization)
* Both male and female
* Age from 18 to 80 years
* Informed consent to participate in the study signed by the patient. If the patient cannot give consent, informed consent is signed by closest relatives or based on the results of a medical concilium
* The patient (legal representative) agrees to a clinical assessment (examination and / or telephone visit) within 6 months and 12 months and to an angiographic control after 12 months
* Patient has not previously been randomized to this or other ongoing study
* Aneurysm has not previously been treated with endovascular embolization or microsurgical clipping
Exclusion Criteria:
* The target aneurysm has been treated (embolization or clipping) before
* Severe clinical condition of the patient (Glasgow coma scale \<4, unstable hemodynamics)
* Lack of signed informed consent
* Severe medical or surgical comorbidity in which the patient's life expectancy is less than 2 years
* Pregnancy, breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04548856
Study Brief:
Protocol Section:
NCT04548856