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

Last updated: October 15, 2024
Sponsor: Ji Xunming,MD,PhD
Overall Status: Completed

Phase

N/A

Condition

Thrombosis

Treatment

the dedicated venous sinus thrombectomy stent

balloon catheter thrombectomy

Clinical Study ID

NCT05291585
CVST-EVT
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Severe form of CVT with a high chance of incomplete recovery, as defined by thepresence of one or more of the following risk factors

  3. Clinical deterioration or progression despite anticoagulation

  4. Stupor, Coma (Glasgow coma scale < 9) or mental status disorder

  5. Involvement of multiple sinus veins results in severe high cranial pressure andrapid vision loss

  6. Venous infarction or intracranial hemorrhage with high load venous sinusthrombosis

  7. Thrombosis of the straight sinus

  8. The subject (or his/her guardian) agrees to participate in this study and signs theinformed consent

Exclusion

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 rectalhemorrhoids) Any known serious condition (such as terminal cancer) with a poor shortterm (1 year) prognosis independent Known allergy against contrast used duringendovascular procedures or the thrombolytic or anticoagulation drug used Previouslylegally incompetent prior to CVST No informed consent Other conditions judged by theresearcher to be unsuitable for inclusion.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: the dedicated venous sinus thrombectomy stent
Phase:
Study Start date:
March 30, 2022
Estimated Completion Date:
July 30, 2023

Study 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.

Connect with a study center

  • Xuan Wu Hospital,Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

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