Clinical trial NCT05291585: The Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus Thrombosis.
Official title: Safety and Efficacy of the Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus Thrombosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Venous Sinus Thrombosis
Keywords: cerebral venous sinus thrombosis
endovascular treatment
thrombectomy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 endovascular treatment of cerebral venous sinus thrombosis.

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 therapy. However, due to the vascular anatomic and pathophysiological differences, the present used devices,such as stent retriever for arterial occlusion ,aspiration system and balloon catheter cannot provide optimal restoration of venous outflow for high load venous sinus thrombosis.This is a prospective, single-center, open-label, randomized, controlled , non-inferiority clinical trial to evaluate the safety and efficacy of the dedicated venous sinus thrombectomy stent ,which is a novel NiTi- braided Stent Retriever compared to balloon catheter used before in our center. Patients are eligible if they have a radiologically proven CVST, a high probability of poor outcome.

The trial aims to randomize 60 patients with a 1:1 allocation to receive the dedicated venous sinus thrombectomy stent or balloon catheter.

The primary outcome is the success rate of immediate recanalization.The most important secondary outcomes are mRS and mortality rate at 90 days. The intracranial hemorrhage and other adverse events after post-operative 24 hours and 7 days are the principal safety outcomes.

Eligibility criteria: Inclusion Criteria:

1. Cerebral venous sinus thrombosis (from onset to randomization less than 28 days) confirmed by cerebral angiography, magnetic resonance venography or computed tomographic venography
2. 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

   1. Clinical deterioration or progression despite anticoagulation
   2. Stupor, Coma (Glasgow coma scale \< 9) or mental status disorder
   3. Involvement of multiple sinus veins results in severe high cranial pressure and rapid vision loss
   4. Venous infarction or intracranial hemorrhage with high load venous sinus thrombosis
   5. Thrombosis of the straight sinus
3. The subject (or his/her guardian) agrees to participate in this study and signs the informed consent

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

1. documented generalized bleeding disorder
2. concurrent thrombocytopenia (\<100 x 10E9/L)
3. severe hepatic or renal dysfunction, that interferes with normal coagulation
4. 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.

Primary outcomes:
measure: Success rate of immediate recanalization
timeFrame: immediately intra-operative
Secondary outcomes:
measure: The proportion of functional independence (modified Rankin score 0-2)
timeFrame: up to 7 days and 90 days post-procedure
measure: The time of thrombectomy procedure
timeFrame: intra-operative
measure: Changes in NIHSS score
timeFrame: pre-procedure, up to 7 days and 90 days post-procedure
measure: Success rate of instrument operation
timeFrame: intra-operative
measure: The proportion of symptom-free and improved
timeFrame: up to 7 days and 90 days post-procedure
measure: CSF opening pressure
timeFrame: up to 7days
measure: Modified Rankin Scale
timeFrame: up to 7 days and 90 days post-procedure
measure: The incidence of symptomatic intracranial hemorrhage
timeFrame: within 7 days post-procedure
measure: Peri-procedural complications
timeFrame: intra-operative and 7 days post-procedure
measure: All cause mortality
timeFrame: within 90 days post-procedure
measure: Incidence of device defects
timeFrame: intra-operative
measure: Incidence of SAE (serious adverse events) or AE (adverse events)
timeFrame: intra-operative, 24 hours, 7 days and 90 days post-procedure
measure: The recurrence rate of CVST
timeFrame: up to 7 days and 90 days post-procedure
Other outcomes:
measure: CVST pathological markers
timeFrame: pre-procedure, intra-operative, up to 7 days
measure: Imaging database
timeFrame: pre-procedure and 90 days post-procedure
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital，Capital Medical University
state: Beijing
Study officials:
References:
citation: Ferro JM, Canhao P, Stam J, Bousser MG, Barinagarrementeria F; ISCVT Investigators. Prognosis of cerebral vein and dural sinus thrombosis: results of the International Study on Cerebral Vein and Dural Sinus Thrombosis (ISCVT). Stroke. 2004 Mar;35(3):664-70. doi: 10.1161/01.STR.0000117571.76197.26. Epub 2004 Feb 19.
citation: Lee SK, Mokin M, Hetts SW, Fifi JT, Bousser MG, Fraser JF; Society of NeuroInterventional Surgery. Current endovascular strategies for cerebral venous thrombosis: report of the SNIS Standards and Guidelines Committee. J Neurointerv Surg. 2018 Aug;10(8):803-810. doi: 10.1136/neurintsurg-2018-013973. Epub 2018 Jun 5. No abstract available.
citation: Coutinho JM, Zuurbier SM, Bousser MG, Ji X, Canhao P, Roos YB, Crassard I, Nunes AP, Uyttenboogaart M, Chen J, Emmer BJ, Roosendaal SD, Houdart E, Reekers JA, van den Berg R, de Haan RJ, Majoie CB, Ferro JM, Stam J; TO-ACT investigators. Effect of Endovascular Treatment With Medical Management vs Standard Care on Severe Cerebral Venous Thrombosis: The TO-ACT Randomized Clinical Trial. JAMA Neurol. 2020 Aug 1;77(8):966-973. doi: 10.1001/jamaneurol.2020.1022.
citation: Fan Y, Yu J, Chen H, Zhang J, Duan J, Mo D, Zhu W, Wang B, Ouyang F, Chen Y, Lan L, Zeng J; Chinese Stroke Association Stroke Council CVST Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of cerebral venous sinus thrombosis. Stroke Vasc Neurol. 2020 Jun;5(2):152-158. doi: 10.1136/svn-2020-000358. Epub 2020 May 13.
citation: Goyal M, Fladt J, Coutinho JM, McDonough R, Ospel J. Endovascular treatment for cerebral venous thrombosis: current status, challenges, and opportunities. J Neurointerv Surg. 2022 Aug;14(8):788-793. doi: 10.1136/neurintsurg-2021-018101. Epub 2022 Jan 12.