Acute Ischemic Stroke, Large Vessel Occlusion, Mechanical Thrombectomy, Stroke
Conditions
Keywords
Stroke, Mechanical Thrombectomy
Brief summary
The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).
Detailed description
The purpose of this prospective, multi-center, open label study of the RapidPulseTM Aspiration System is to assess the initial technical (performance), effectiveness and safety 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 target sample size is 10 evaluable subjects with a maximum of 50 subjects. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge. The primary endpoint is first pass reperfusion effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt.
Interventions
The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using pulsatile aspiration. The system is comprised of a sterile one-time use 071 catheter, a sterile one-time use tubing set and a multiuse aspiration pump console.
Sponsors
RapidPulse, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, open-label, single-arm study to assess the initial technical (performance), effectiveness, and safety of the RapidPulseTM Aspiration System. 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
* Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours. * CTA, MRA or DSA demonstrating anterior large vessel occlusion involving the intracranial ICA, MCA M1 or M2 segments, basilar or vertebral artery * Target occlusion can be accessed by the RapidPulseTM 071 aspiration catheter assessed at the time of the index procedure. Enrollment will be defined by the successful navigation of the RapidPulseTM 071 aspiration catheter into the occlusion site.
Exclusion criteria
* Known or suspected ICAD * Tandem occlusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Pass Reperfusion Effect (FPE) | Intra-procedural | The number of subjects with mTICI ≥ 2c after one reperfusion attempt |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frontline technical success | Intra-procedural | The number of subjects with mTICI ≥ 2b after the last pass with Study Device (no rescue therapy) |
| Final mTICI score | Intra-procedural | The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy) |
| Modified First Pass Reperfusion Effect (mFPE) | Intra-procedural | The number of subjects with mTICI ≥ 2b after one device pass |
| Device-related and procedure-related adverse events | Intra and post procedural (up to Day 5-7 or discharge whichever occurs earlier) | Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm |
Countries
Paraguay, Turkey (Türkiye)
Outcome results
None listed