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

Safety and Efficacy of the Dedicated Venous Sinus Thrombectomy Stent for Endovascular Treatment of Cerebral Venous Sinus Thrombosis.

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Venous Sinus Thrombosis
• Intervention / Treatment: Device: the dedicated venous sinus thrombectomy stent; Device: balloon catheter thrombectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuan Wu Hospital，Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the dedicated venous sinus thrombectomy stent; 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; the dedicated venous sinus thrombectomy stent in conjunction with aspiration for CVST patients within 28 days of symptom onset.
Active Comparator: balloon catheter thrombectomy; Intracranial thrombectomy was balloon catheter in conjunction with aspiration performed with a control product	Device: balloon catheter thrombectomy; Intracranial thrombectomy was conducted by using a balloon catheter in conjunction with aspiration as control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of functional independence (modified Rankin score 0-2)	0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.	up to 7 days and 90 days post-procedure
The time of thrombectomy procedure	The time of thrombectomy procedure refers to the time from entry of thrombectomy device to vascular recanalization) or the end time of surgery for patients with no vascular recanalization	intra-operative
Changes in NIHSS score	Changes in NIHSS score 7days or at discharge and 90 days post-procedure compared with pre-procedure.	pre-procedure, up to 7 days and 90 days post-procedure
Success rate of instrument operation	Device operation success = the number of devices completed conveying to the occlusive segment of the sinus, releasing and retracting in the group/the number of all test devices used in the group ×100%	intra-operative
The proportion of symptom-free and improved	The symptoms include headache, visual dysfunction, tinnitus, cognitive disorder and epilepsy, etc.	up to 7 days and 90 days post-procedure
CSF opening pressure	Change of CSF opening pressure 7 days or at discharge post-procedure compared with pre-procedure by lumbar puncture	up to 7days
Modified Rankin Scale	Distribution of Modified Rankin Scale	up to 7 days and 90 days post-procedure
The incidence of symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage within 7 days post-procedure, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, an ventricular hemorrhage) accompanied by neurological deterioration (NIHSS score increased by ≥4 points compared with pre-procedure.	within 7 days post-procedure
Peri-procedural complications	Procedure associated complications: vasospasm, dissection, perforation and emboli to new territory.	intra-operative and 7 days post-procedure
All cause mortality	All cause mortality within 90 days post-procedure	within 90 days post-procedure
Incidence of device defects	Defects of research devices during clinical trials, such as operational difficulties, broken devices and any incident related with device defects.	intra-operative
Incidence of SAE (serious adverse events) or AE (adverse events)	Incidence of SAE (serious adverse events) or AE (adverse events) intra-operative, 24 hours, 7 days and 90 days post-procedure	intra-operative, 24 hours, 7 days and 90 days post-procedure
The recurrence rate of CVST	The recurrence rate of CVST confirmed by clinical manifestations and imaging examinations	up to 7 days and 90 days post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CVST pathological markers	CVST pathological markers of blood, clot and cerebral spinal fluid(CRP,IL-6,NSE,NLR,etc.	pre-procedure, intra-operative, up to 7 days
Imaging database	neuroimaging: MRV/CTV	pre-procedure and 90 days post-procedure

Collaborators and Investigators

• Sponsor: Ji Xunming,MD,PhD

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: endovascular treatment; cerebral venous sinus thrombosis; thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Intracranial Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Thrombosis; Sinus Thrombosis, Intracranial
• Other Study ID Numbers: CVST-EVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No