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A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.
The purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RapidPulseTM Aspiration System | Device | The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System |
| Measure | Description | Time Frame |
|---|---|---|
| First Pass Reperfusion Effect (FPE) | Defined by mTICI greater than or equal to 2c after one reperfusion attempt | Intra-procedural |
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| Measure | Description | Time Frame |
|---|---|---|
| Frontline Technical Success | As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy) | Intra-procedural |
| Final mTICI | After all passes (including any rescue therapy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul G Nogueira, MD | University of Pittsburgh Medical Center Stroke Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Surgery | Tbilisi | Georgia | ||||
| Pineo Medical Ecosystems |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | 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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Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.
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| Intra-procedural |
| Modified First Pass Reperfusion Effect (mFPE) | Defined as mTICI 2b or greater after one device pass | Intra-procedural |
| Device-related and procedure-related adverse events | Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm | Intra and post-procedural (up to 24 hours) |
| Tbilisi |
| Georgia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |