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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2023-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Venous Sinus Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

the dedicated venous sinus thrombectomy stent

Intervention Type DEVICE

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

balloon catheter thrombectomy

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

Group Type ACTIVE_COMPARATOR

balloon catheter thrombectomy

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

balloon catheter thrombectomy

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No