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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombectomy | Experimental | Aspiration of clot with large bore catheter in acute ischemic stroke patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombectomy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Procedure |
| Device-related peri-procedural complications | dissection or perforation | 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 | 24 hour |
| Embolization to a previously uninvolved territory | Embolization to a previously uninvolved territory | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours after treatment |
| Modified Rankin Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Brew, MBChB, MHB | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Auckland | 1023 | New Zealand | |||
| Christchurch Hospital |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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
| 90 days after treatment |
| Procedure Time | Total procedure time from insertion of Route 92 Reperfusion System to final angiogram | Procedure |
| Procedure-Related SAEs | Serious Adverse Events related to the interventional procedure | Procedure |
| Christchurch |
| 8011 |
| New Zealand |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |