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This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThrombX Retriever | Experimental | Access to the involved vasculature and preform mechanical thrombectomy using the ThrombX Retriever. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical thrombectomy with ThrombX Retriever | Device | Revascularization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever | Defined by a mTICI score >2b | Up to the end of theprocedure |
| Safety Endpoint | Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Functional independence defined by modified Rankin Scale (mRS) | modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. | 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Houston, MS | Contact | 65052453467 | chouston@thrombxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahesh Jayaraman, MD | Rhode Island Hospital | Principal Investigator |
| Raul Nogueira, MD, MD | University of Pittsburgh Medical Center | Principal Investigator |
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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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Single group assignment
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |