Acute Ischemic Stroke
Conditions
Keywords
Stroke, Large Vessel Occlusion, Mechanical Thrombectomy, Neurovascular Intervention
Brief summary
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.
Detailed description
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.
Interventions
The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System
Sponsors
RapidPulse, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours * Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery * Target occlusion can be accessed by the Medtronic React 71 aspiration catheter
Exclusion criteria
* Known or suspected intracranial atherosclerotic disease (ICAD) * Tandem occlusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Pass Reperfusion Effect (FPE) | Intra-procedural | Defined by mTICI greater than or equal to 2c after one reperfusion attempt |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frontline Technical Success | Intra-procedural | As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy) |
| Final mTICI | Intra-procedural | After all passes (including any rescue therapy) |
| Modified First Pass Reperfusion Effect (mFPE) | Intra-procedural | Defined as mTICI 2b or greater after one device pass |
| Device-related and procedure-related adverse events | Intra and post-procedural (up to 24 hours) | Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm |
Countries
Georgia
Outcome results
None listed