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A multicenter, single-group target-value clinical trial to evaluate the safety and efficacy of venous thrombectomy stent for endovascular treatment of cerebral venous sinus thrombosis

A prospective, multicenter, single-group target-value clinical trial to evaluate the safety and efficacy of the dedicated venous thrombectomy stent for endovascular treatment of cerebral venous sinus thrombosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057621
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-14
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Venous Sinus Thrombosis

Interventions

experimental group:Venous Thrombectomy Stent

Sponsors

Xuanwu Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-70 years; 2. Cerebral venous sinus thrombosis (from onset to diagnosis less than 28 days) confirmed by cerebral angiography, magnetic resonance venography or computed tomographic venography; 3. 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 or mental status disorder; (3) Involvement of multiple sinus veins results in severe high cranial pressure or rapid vision loss; (4) Venous infarction or intracranial hemorrhage with high load venous sinus thrombosis; (5) Thrombosis of the deep cerebral venous system and straight sinus; 4. Life expectancy > 1 year; 5. The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Isolated cavernous sinus thrombosis or isolated cortical vein thrombosis; 2. mRS > 2 before CVST; 3. Clinical and radiological signs of impending transtentorial herniation due to large space-occupying lesions , which requires emergency decompression; 4. Recurrent CVST; 5. Pregnancy (Excluding women more than 6 weeks postpartum); 6. Recent (< 2 weeks) major surgical procedure or severe cranial trauma; 7. Any known serious condition (such as terminal cancer) with a poor short term (<1 year) prognosis; 8. Contraindication for anti-coagulant or thrombolytic treatment; (1) Documented generalized bleeding disorder; (2) Thrombocytopenia (<100 x 10^9/L); (3) Severe hepatic or renal dysfunction, that interferes with normal coagulation; (4) Gastrointestinal tract hemorrhage (< 3 months, not including hemorrhage from rectal hemorrhoids); 9. Known allergy to nickel and titanium; 10. Known allergy against contrast used during endovascular procedures or the thrombolytic or anticoagulation drug used; 11. Patients who had participated in other clinical trials within three months; 12. Other conditions judged by the researcher to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Immediately postoperative recanalization rate;

Secondary

MeasureTime frame
The time of thrombectomy procedure;The ratio of functional independence (modified Rankin score 0-2);Glasgow coma scale (GCS);The proportion of symptom-free and improved;Lumbar puncture cerebrospinal fluid pressure;The recurrence rate of cerebral venous sinus thrombosis;

Countries

China

Contacts

Public ContactJi Xunming

Xuanwu Hospital Affiliated to Capital Medical University

jixm@ccmu.edu.cn+86 13911077166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026