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 range18 Years – 70 Years

SexALL

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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)
✕. 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.

What they're measuring

Success rate of immediate recanalization

Timeframe: immediately intra-operative

Trial details

NCT IDNCT05291585

SponsorJi Xunming,MD,PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-26

View on ClinicalTrials.gov More Cerebral Venous Sinus Thrombosis trials