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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT04532333
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 80 years, any gender
* intracranial aneurysms ruptured in 14 days
* Diagnosed as subarachnoid hemorrhage (SAH) by CT, confirmed aneurysmal SAH by DSA
* Hunt-Hess I-III
* Patient is suitable for coil embolization
* Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements
Exclusion Criteria:
* Nonsaccular Aneurysms (include infective, fusiform, dissecting aneurysms)
* Prior intracranial aneurysms
* Poor baseline of mRS 4-5
* Aneurysms that cannot be successfully treated by interventional treatment judged by clinician.
* Patients cannot receive antiplatelet aggregation or anticoagulant therapy
* Patients with indications for emergency craniotomy: intracranial hematoma, high intracranial pressure or hydrocephalus etc..
* Patients with AVM, intracranial artery stenosis or moyamoya disease
* Pregnancy or lactation
* Patients with severe abnormal function of main organs, liver or kidney
* Other serious diseases not suitable for this study
* Patients are currently participating in another drug-related clinical study
* Patients are allergic to heparin or bivalirudin and its excipients or hirudin
* Patients with a clear history of allergy to coil embolic material
* Patients had or may have had severe reactions to contrast media that could not complete the preoperative medication
* Patients are not suitable to participate in this clinical study judged by clinician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04532333
Study Brief:
Protocol Section:
NCT04532333