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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT07214220
Eligibility Criteria:
Inclusion Criteria:
Subject age ≥ 18 and ≤ 75 years
Subject has a pre-procedure mRS ≤ 3
Subject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured
Subject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document
Parent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.
Exclusion Criteria:
Subjects with a minimum platelet count of \< 100,000/μL.
Subjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days.
Subject has an acutely ruptured aneurysm with a Hunt \& Hess score ≥ 4
Subject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography
Subject has challenging anatomy that in the investigator's opinion is not suitable for safe delivery of an 0.021" catheter, including stenosis \> 70% or excessive tortuosity
Subject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year
Subject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements.
Subject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke
Subject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication
Subject has ipsilateral carotid or vertebral artery stenosis greater than 50%
Subject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment.
Subject has serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
Subject has severe intracranial vasospasm not responsive to medical therapy
Subject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis
The subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial
Subject is currently participating in another clinical research trial involving an investigational device or drug
Subject is under judicial protection or legal guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07214220
Study Brief:
Protocol Section:
NCT07214220