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Cerebral Venous Sinus ThrombosisNCT05291585

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

A study testing the dedicated venous sinus thrombectomy stent and balloon catheter thrombectomy in people with Cerebral Venous Sinus Thrombosis, run by Ji Xunming,MD,PhD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cerebral Venous Sinus Thrombosis
What is being tested?
the dedicated venous sinus thrombectomy stent and balloon catheter thrombectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 Mar 2022to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuan Wu Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
the dedicated venous sinus thrombectomy stent, balloon catheter thrombectomy
Keywords
cerebral venous sinus thrombosis, endovascular treatment, thrombectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the dedicated venous sinus thrombectomy stentDevice

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

  • balloon catheter thrombectomyDevice

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

Study groups in NCT05291585
Study groupRoleWhat they receive
the dedicated venous sinus thrombectomy stentExperimentalPatients 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.
Receives: Device: the dedicated venous sinus thrombectomy stent
balloon catheter thrombectomyActive comparatorIntracranial thrombectomy was balloon catheter in conjunction with aspiration performed with a control product
Receives: Device: balloon catheter thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately intra-operative

Secondary outcomes (13)

  1. 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.

    Measured: up to 7 days and 90 days post-procedure

  2. 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

    Measured: intra-operative

  3. Changes in NIHSS score

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

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

  4. 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%

    Measured: intra-operative

  5. The proportion of symptom-free and improved

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

    Measured: up to 7 days and 90 days post-procedure

  6. CSF opening pressure

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

    Measured: up to 7days

  7. Modified Rankin Scale

    Distribution of Modified Rankin Scale

    Measured: up to 7 days and 90 days post-procedure

  8. 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.

    Measured: within 7 days post-procedure

  9. Peri-procedural complications

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

    Measured: intra-operative and 7 days post-procedure

  10. All cause mortality

    All cause mortality within 90 days post-procedure

    Measured: within 90 days post-procedure

  11. Incidence of device defects

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

    Measured: intra-operative

  12. 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

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

  13. The recurrence rate of CVST

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

    Measured: up to 7 days and 90 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start30 Mar 2022
  3. Primary completion26 Mar 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05291585
Sponsor's protocol ID
CVST-EVT
Status last verified
Oct 2024
First submitted
2 Mar 2022
Last updated
17 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 14976332

  • 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.

    PubMed 29871990

  • 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.

    PubMed 32421159

  • 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.

    PubMed 32409571

  • 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.

    PubMed 35022302

  • 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.

    PubMed 39601121

Questions about this trial

What is this clinical trial studying?

A study testing the dedicated venous sinus thrombectomy stent and balloon catheter thrombectomy in people with Cerebral Venous Sinus Thrombosis, run by Ji Xunming,MD,PhD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of immediate recanalization (time frame: immediately intra-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291585, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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