The objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the Cerebrovascular Interventional Procedural Control System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The Cerebrovascular Interventional Procedural Control System is intended for use in the remote delivery and manipulation of guidewires and rapid deliver stent catheters, and remote manipulation of guide catheters during cerebrovascular intervention procedures.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGGood Neurological Outcome
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms.
Time frame: 90±7 Days post-treatment
Technical Success
Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.
Time frame: Immediately post-treatment
Successful Revascularization
Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy.
Time frame: Immediately post-treatment
Time from Groin Puncture to Reperfusion
Time from groin puncture to achievement of mTICI ≥2b
Time frame: Immediately post-treatment
Successful Recanalization Rate
Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy.
Time frame: Immediately post-treatment
Radiation Exposure
Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.
Time frame: Immediately post-treatment
Symptomatic Intracranial Hemorrhage
Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
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Time frame: 36 hours post-treatment
Device-related Serious Adverse Events (SAEs)
Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm.
Time frame: Through 90 days
All-cause Mortality at 90 days
Rate of mortality
Time frame: Through 90 days