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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
the dedicated venous sinus thrombectomy stent in conjunction with aspiration for CVST patients within 28 days of symptom onset.
Intracranial thrombectomy was conducted by using a balloon catheter in conjunction with aspiration as control group.
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
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.
Time frame: immediately intra-operative
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.
Time frame: up to 7 days and 90 days post-procedure
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
Time frame: intra-operative
Changes in NIHSS score
Changes in NIHSS score 7days or at discharge and 90 days post-procedure compared with pre-procedure.
Time frame: pre-procedure, up to 7 days and 90 days post-procedure
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%
Time frame: intra-operative
The proportion of symptom-free and improved
The symptoms include headache, visual dysfunction, tinnitus, cognitive disorder and epilepsy, etc.
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Time frame: up to 7 days and 90 days post-procedure
CSF opening pressure
Change of CSF opening pressure 7 days or at discharge post-procedure compared with pre-procedure by lumbar puncture
Time frame: up to 7days
Modified Rankin Scale
Distribution of Modified Rankin Scale
Time frame: up to 7 days and 90 days post-procedure
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.
Time frame: within 7 days post-procedure
Peri-procedural complications
Procedure associated complications: vasospasm, dissection, perforation and emboli to new territory.
Time frame: intra-operative and 7 days post-procedure
All cause mortality
All cause mortality within 90 days post-procedure
Time frame: within 90 days post-procedure
Incidence of device defects
Defects of research devices during clinical trials, such as operational difficulties, broken devices and any incident related with device defects.
Time frame: intra-operative
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
Time frame: intra-operative, 24 hours, 7 days and 90 days post-procedure
The recurrence rate of CVST
The recurrence rate of CVST confirmed by clinical manifestations and imaging examinations
Time frame: up to 7 days and 90 days post-procedure