Status:
COMPLETED
The Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus Thrombosis.
Lead Sponsor:
Ji Xunming,MD,PhD
Conditions:
Cerebral Venous Sinus Thrombosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
Endovascular mechanical thrombectomy is reserved for the treatment of refractory cerebral venous sinus thrombosis (CVST) in the scenario of clinical deterioration in spite of appropriate anticoagulant...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05291585
Start Date
March 30 2022
End Date
July 30 2023
Last Update
October 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100053