Phase
Condition
Thrombosis
Treatment
the dedicated venous sinus thrombectomy stent
balloon catheter thrombectomy
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cerebral venous sinus thrombosis (from onset to randomization less than 28 days)confirmed by cerebral angiography, magnetic resonance venography or computedtomographic venography
Severe form of CVT with a high chance of incomplete recovery, as defined by thepresence 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 andrapid vision loss
Venous infarction or intracranial hemorrhage with high load venous sinusthrombosis
Thrombosis of the straight sinus
The subject (or his/her guardian) agrees to participate in this study and signs theinformed consent
Exclusion
Exclusion Criteria:
Age less than 18 years Duration from onset to randomization more than 28 days Recurrent CVST Pregnancy (women in the puerperium may be included) Isolated cavernous sinus thrombosis or isolated cortical vein thrombosis Clinical and radiological signs of impending transtentorial herniation due to large space-occupying lesions and 4th ventricle compression and hydrocephalus, which requires emergency surgery Recent (< 2 weeks) major surgical procedure (does not include lumbar puncture) or severe cranial trauma Contraindication for anti-coagulant or thrombolytic treatment
documented generalized bleeding disorder
concurrent thrombocytopenia (<100 x 10E9/L)
severe hepatic or renal dysfunction, that interferes with normal coagulation
gastrointestinal tract hemorrhage (< 3 months, not including hemorrhage from rectalhemorrhoids) Any known serious condition (such as terminal cancer) with a poor shortterm (1 year) prognosis independent Known allergy against contrast used duringendovascular procedures or the thrombolytic or anticoagulation drug used Previouslylegally incompetent prior to CVST No informed consent Other conditions judged by theresearcher to be unsuitable for inclusion.
Study Design
Study Description
Connect with a study center
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing 100053
ChinaSite Not Available

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