The Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus… (NCT05291585) | Clinical Trial Compass
CompletedNot Applicable
The Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus Thrombosis.
China60 participantsStarted 2022-03-30
Plain-language summary
A prospective, single-center, open-label,randomized, controlled,non-inferiority clinical trial will be conducted to evaluate the safety and efficacy of a dedicated venous sinus thrombectomy stent for endovascular treatment of cerebral venous sinus thrombosis.
Who can participate
Age range
18 Years – 70 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
. Cerebral venous sinus thrombosis (from onset to randomization less than 28 days) confirmed by cerebral angiography, magnetic resonance venography or computed tomographic venography
. Severe form of CVT with a high chance of incomplete recovery, as defined by the presence of one or more of the following risk factors
. Clinical deterioration or progression despite anticoagulation
. Stupor, Coma (Glasgow coma scale \< 9) or mental status disorder
. Involvement of multiple sinus veins results in severe high cranial pressure and rapid vision loss
. Venous infarction or intracranial hemorrhage with high load venous sinus thrombosis
. Thrombosis of the straight sinus
. The subject (or his/her guardian) agrees to participate in this study and signs the informed consent
Exclusion criteria
. documented generalized bleeding disorder
. concurrent thrombocytopenia (\<100 x 10E9/L)
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.
. severe hepatic or renal dysfunction, that interferes with normal coagulation
. gastrointestinal tract hemorrhage (\< 3 months, not including hemorrhage from rectal hemorrhoids) Any known serious condition (such as terminal cancer) with a poor short term (1 year) prognosis independent Known allergy against contrast used during endovascular procedures or the thrombolytic or anticoagulation drug used Previously legally incompetent prior to CVST No informed consent Other conditions judged by the researcher to be unsuitable for inclusion.