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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.