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

Primary Purpose

Cerebral Venous Sinus Thrombosis

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

the dedicated venous sinus thrombectomy stent

balloon catheter thrombectomy

About this trial

This is an interventional treatment trial for Cerebral Venous Sinus Thrombosis focused on measuring cerebral venous sinus thrombosis, endovascular treatment, thrombectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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
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

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.

Sites / Locations

Xuan Wu Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the dedicated venous sinus thrombectomy stent

balloon catheter thrombectomy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Changes in NIHSS score

Changes in NIHSS score 7days or at discharge and 90 days post-procedure compared with pre-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%

The proportion of symptom-free and improved

The symptoms include headache, visual dysfunction, tinnitus, cognitive disorder and epilepsy, etc.

CSF opening pressure

Change of CSF opening pressure 7 days or at discharge post-procedure compared with pre-procedure by lumbar puncture

Modified Rankin Scale

Distribution of Modified Rankin Scale

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.

Peri-procedural complications

Procedure associated complications: vasospasm, dissection, perforation and emboli to new territory.

All cause mortality

All cause mortality 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.

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

The recurrence rate of CVST

The recurrence rate of CVST confirmed by clinical manifestations and imaging examinations

Full Information

NCT ID

NCT05291585

First Posted

March 2, 2022

Last Updated

March 13, 2022

Sponsor

Ji Xunming,MD,PhD

1. Study Identification

Unique Protocol Identification Number

NCT05291585

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ji Xunming,MD,PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Venous Sinus Thrombosis

Keywords

cerebral venous sinus thrombosis, endovascular treatment, thrombectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the dedicated venous sinus thrombectomy stent

Arm Type

Experimental

Arm Description

Arm Title

balloon catheter thrombectomy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

the dedicated venous sinus thrombectomy stent

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

balloon catheter thrombectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

Success rate of immediate recanalization

Description

Time Frame

immediately intra-operative

Secondary Outcome Measure Information:

Title

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

Description

0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.

Time Frame

up to 7 days and 90 days post-procedure

Title

The time of thrombectomy procedure

Description

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

Time Frame

intra-operative

Title

Changes in NIHSS score

Description

Changes in NIHSS score 7days or at discharge and 90 days post-procedure compared with pre-procedure.

Time Frame

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

Title

Success rate of instrument operation

Description

Time Frame

intra-operative

Title

The proportion of symptom-free and improved

Description

The symptoms include headache, visual dysfunction, tinnitus, cognitive disorder and epilepsy, etc.

Time Frame

up to 7 days and 90 days post-procedure

Title

CSF opening pressure

Description

Change of CSF opening pressure 7 days or at discharge post-procedure compared with pre-procedure by lumbar puncture

Time Frame

up to 7days

Title

Modified Rankin Scale

Description

Distribution of Modified Rankin Scale

Time Frame

up to 7 days and 90 days post-procedure

Title

The incidence of symptomatic intracranial hemorrhage

Description

Time Frame

within 7 days post-procedure

Title

Peri-procedural complications

Description

Procedure associated complications: vasospasm, dissection, perforation and emboli to new territory.

Time Frame

intra-operative and 7 days post-procedure

Title

All cause mortality

Description

All cause mortality within 90 days post-procedure

Time Frame

within 90 days post-procedure

Title

Incidence of device defects

Description

Defects of research devices during clinical trials, such as operational difficulties, broken devices and any incident related with device defects.

Time Frame

intra-operative

Title

Incidence of SAE (serious adverse events) or AE (adverse events)

Description

Incidence of SAE (serious adverse events) or AE (adverse events) intra-operative, 24 hours, 7 days and 90 days post-procedure

Time Frame

intra-operative, 24 hours, 7 days and 90 days post-procedure

Title

The recurrence rate of CVST

Description

The recurrence rate of CVST confirmed by clinical manifestations and imaging examinations

Time Frame

up to 7 days and 90 days post-procedure

Other Pre-specified Outcome Measures:

Title

CVST pathological markers

Description

CVST pathological markers of blood, clot and cerebral spinal fluid(CRP,IL-6,NSE,NLR,etc.

Time Frame

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

Title

Imaging database

Description

neuroimaging: MRV/CTV

Time Frame

pre-procedure and 90 days post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xunming Ji, MD

Phone

010-83198952

jixm@ccmu.edu.cn

Facility Information:

Facility Name

Xuan Wu Hospital，Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xunming Ji

Phone

010-83198952

jixunming@vip.163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

14976332

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.

Results Reference

background

PubMed Identifier

29871990

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.

Results Reference

background

PubMed Identifier

32421159

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.

Results Reference

background

PubMed Identifier

32409571

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.

Results Reference

background

PubMed Identifier

35022302

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.

Results Reference

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

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