The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients. The study design is an interventional, prospective, single-arm, open label clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
66
The Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries.
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Effectiveness
The primary effectiveness endpoint is arterial revascularization as measured by a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments.
Time frame: Procedure
Device-related peri-procedural complications
dissection or perforation
Time frame: Procedure
Symptomatic Intracranial Cerebral Hemorrhage (SICH)
defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale \[NIHSS\] score of \>=4 points
Time frame: 24 hour
Embolization to a previously uninvolved territory
Embolization to a previously uninvolved territory
Time frame: Procedure
NIHSS score
The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke
Time frame: 24 hours after treatment
Modified Rankin Score
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or who have other causes of neurological disability
Time frame: 90 days after treatment
Procedure Time
Total procedure time from insertion of Route 92 Reperfusion System to final angiogram
Time frame: Procedure
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Procedure-Related SAEs
Serious Adverse Events related to the interventional procedure
Time frame: Procedure