Acute Ischemic Stroke
Conditions
Keywords
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).
Detailed description
The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.
Interventions
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
DEVICEStandard of Care Aspiration Thrombectomy System
Commercially available aspiration catheter with commercially available aspiration pump
Sponsors
RapidPulse, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age 18 years or older * Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours * Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery Key
Exclusion criteria
* Evidence of hemorrhage * Significant mass effect and/or midline shift * Vessel tortuosity too difficult to allow endovascular access per investigator judgment * Severe or fatal co-morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Pass Reperfusion Effect (FPE) | Intra-procedural | Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frontline technical success | Intra-procedural | Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy |
| Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure | 90 days | The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased) |
| Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure | 24 hours | — |
| All cause mortality rate | 90 days | — |
Countries
Brazil, Denmark, Latvia, Spain, Turkey (Türkiye)
Outcome results
None listed