Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis an… (NCT04352218) | Clinical Trial Compass
UnknownPhase 2
Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache
60 participantsStarted 2020-09
Plain-language 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 stenosis and chronic headache resistant to best medical therapy.
After Stage 1, a second stage will be conducted to evaluate the preliminary efficacy.
Who can participate
Age range18 Years
SexALL
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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 st…