Cerebral Venous Sinus Thrombosis Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04269954 -
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
|
Phase 4 | |
| Not yet recruiting |
NCT03919305 -
Cerebral Venous Thrombosis Cohort Study in China Mainland
|
||
| Recruiting |
NCT03273179 -
Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales
|
N/A | |
| Recruiting |
NCT04966182 -
Application CT and MRI in Cerebral Venous Sinus Thrombosis
|
||
| Recruiting |
NCT05021198 -
The Norwegian Cerebral Venous Thrombosis Study
|
||
| Withdrawn |
NCT04580238 -
Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache
|
Phase 1 | |
| Completed |
NCT05448248 -
Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)
|