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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT03373292
Eligibility Criteria:
Inclusion Criteria:
1. Age ranging from 18 to 80 years of age, both genders.
2. Patients diagnosed with IJVS surrounded by abnormally and tortuous collateral veins verified by MRV, CTV and/or DSA.
3. Pressure gradient across the stenotic segments is equal to or greater than 4 mmHg.
4. Intracranial hypertension associated manifestations cannot be satisfactorily controlled by conservative or non-surgical therapies.
5. Informed consent obtained from the patient or his/her health care proxy, able to cooperate follow-up visits.
Exclusion Criteria:
1. External osseous impingement associated IJVS.
2. Contraindication to iodinated contrasts.
3. Contraindication to general anesthesia.
4. Contraindication to standard medical therapy such as Aspirin, Clopidogrel or anticoagulants.
5. Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis.
6. Previous history of major surgeries within 30 days prior to inclusion, or scheduled for any of the procedures within 12 months after inclusion.
7. Severe hematological, hepatic or renal dysfunctions.
8. Current or having a history of chronic physical diseases or mental disorders.
9. Pregnant or lactating women.
10. Life expectancy \< 1 year due to concomitant life-threatening illness.
11. Patients unlikely to be compliant with intervention or return for follow-up visits.
12. No signed consent from the patient or available legally authorized representatives.
13. Patients recruited to other clinical trials with medications or devices, which may affect the outcome of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03373292
Study Brief:
Protocol Section:
NCT03373292