An interventional study of Thrombectomy in Acute Ischemic Stroke, sponsored by Route 92 Medical, Inc.. Completed at 2 sites in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Route 92 Medical, Inc. · Not applicable, Interventional, and Device feasibility
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.
This study's enrollment of 66 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Route 92 Medical, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aspiration of clot with large bore catheter in acute ischemic stroke patients
Device: Thrombectomy
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.
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
Procedure-Related SAEs
Serious Adverse Events related to the interventional procedure
Time frame: Procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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