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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT04352218
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged ≥ 18
* Patients undergoing Echo color Doppler ultrasound with unilateral or bilateral non-thrombotic stenosis \> 50% of IJV
* Patients suffering from headache not responsive to two medical treatments with diagnosis of chronic migraine or chronic tension-type headache according to the criteria of the International Classification of Headache Disorders (ICHD-3 beta).
* Subject able to comprehend the full nature and purpose of the study, including possible risks and side effects; able to co-operate with the Investigator and to comply with the requirements of the entire study.
* Subject available for the whole study period and gave written informed consent prior to inclusion in the study
Exclusion Criteria:
* Patients with unilateral or bilateral thrombosis stenosis of IJV.
* Patients with severe hypoplasia of IJV with diameter \< 5mm.
* Presence of pacemaker.
* Dural venous sinus stenosis \> 50%
* Documented severe intolerance to iodinated contrast medium.
* Non-compliance with pharmacological treatment
* Intracranial abnormalities such as tumor, abscess and vascular malformation.
* Severe hematological, hepatic or renal dysfunction (end-stage renal disease on dialysis will not be a contraindication).
* Life expectancy \< 1 year
* Known or potential hypersensitivity to anticoagulant or antiplatelet drugs or one of the components and/or history of allergic reactions in general, which the Investigator considers important for study participation.
* Any evidence of severe or uncontrolled systemic diseases, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardies compliance with the protocol
* Females of childbearing potential will be excluded from participation in the study if they meet any one of the following conditions:
* are currently pregnant or,
* have a positive result on the urine pregnancy test or,
* intend to become pregnant during the study treatment period or, • are breast-feeding or,
* not willing to use highly effective birth control measures during the entire course of the study treatment period
* History of alcohol or drug abuse
* Enrollment in another study protocol within 30 days prior to randomization
* Any other significant disorders, which, in the opinion of the investigator, may influence the participation in the study or affect study result.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04352218
Study Brief:
Protocol Section:
NCT04352218