The Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus Thrombosis.

NCT05291585 | Completed

• 1 other identifier: CVST-EVT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Venous Sinus Thrombosis

Keywords

cerebral venous sinus thrombosis; endovascular treatment; thrombectomy

Outcome Measures

Primary Outcomes (1)

• Success rate of immediate recanalization

  3-grade classification scheme that considers different grades for patients with complete recanalization, partial recanalization and no recanalization. Complete recanalization defined as blood flow without any interruption, Partial recanalization defined as small interruptions of continuous blood flow and narrowing of the venous lumen No recanalization defined as interrupted blood flow.

  immediately intra-operative

Secondary Outcomes (13)

• The proportion of functional independence (modified Rankin score 0-2)

  up to 7 days and 90 days post-procedure

• The time of thrombectomy procedure

  intra-operative

• Changes in NIHSS score

  pre-procedure, up to 7 days and 90 days post-procedure

• Success rate of instrument operation

  intra-operative

• The proportion of symptom-free and improved

  up to 7 days and 90 days post-procedure

Other Outcomes (2)

• CVST pathological markers

  pre-procedure, intra-operative, up to 7 days

• Imaging database

  pre-procedure and 90 days post-procedure

Study Arms (2)

the dedicated venous sinus thrombectomy stent

EXPERIMENTAL

Patients diagnosed with acute or subacute venous sinus thrombosis within 28days from the onset of symptoms to endovascular treatment, regardless of whether anticoagulation has been performed. The dedicated venous sinus thrombectomy stent can be used to remove the thrombus to restore sinus blood flow.

Device: the dedicated venous sinus thrombectomy stent

balloon catheter thrombectomy

ACTIVE COMPARATOR

Intracranial thrombectomy was balloon catheter in conjunction with aspiration performed with a control product

Device: balloon catheter thrombectomy

Interventions

the dedicated venous sinus thrombectomy stent DEVICE

the dedicated venous sinus thrombectomy stent in conjunction with aspiration for CVST patients within 28 days of symptom onset.

the dedicated venous sinus thrombectomy stent

balloon catheter thrombectomy DEVICE

Intracranial thrombectomy was conducted by using a balloon catheter in conjunction with aspiration as control group.

balloon catheter thrombectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ji Xunming,MD,PhD: lead

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (6)

• 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.

  PMID: 14976332 BACKGROUND

• 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.

  PMID: 29871990 BACKGROUND

• 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.

  PMID: 32421159 BACKGROUND

• 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.

  PMID: 32409571 BACKGROUND

• 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.

  PMID: 35022302 BACKGROUND

• Xu Y, Wu Y, Jiang M, Song B, Li C, Wu C, Duan J, Meng R, Zhou C, Li S, Yan F, Chen J, Li M, Ji X. Efficacy and Safety of a Dedicated Device for Cerebral Venous Thrombectomy: A Pilot Randomized Clinical Trial. Stroke. 2025 Jan;56(1):5-13. doi: 10.1161/STROKEAHA.124.045607. Epub 2024 Nov 27.

  PMID: 39601121 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 22, 2022
• Study Start: March 30, 2022
• Primary Completion: March 26, 2023
• Study Completion: July 30, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

CN (1)