Status:
UNKNOWN
Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache
Lead Sponsor:
University of Catania
Conditions:
Headache
Jugular Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess, as first stage, the safety profile of an innovative venous- oriented device (Petalo CVS) in the treatment of patients with non-thrombotic internal jugular vein s...
Detailed Description
Chronic headache is a disabling neurologic condition that affects 2-3 % of the general population. According to Headache Classification Committee of the International Headache Society, the chronic hea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04352218
Start Date
September 1 2020
End Date
April 1 2022
Last Update
June 2 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.