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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).
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.
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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 the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RapidPulseTM Aspiration System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| First Pass Reperfusion Effect (FPE) | The number of subjects with mTICI ≥ 2c after one reperfusion attempt | Intra-procedural |
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| Measure | Description | Time Frame |
|---|---|---|
| Frontline technical success | The number of subjects with mTICI ≥ 2b after the last pass with Study Device (no rescue therapy) | Intra-procedural |
| Final mTICI score | The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul G Nogueira | University of Pittsburgh Medical Center Stroke Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción | Asunción | Paraguay | ||||
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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 (performance), effectiveness, and safety of the RapidPulseTM Aspiration System. As such, no formal statistical hypothesis will be tested in this study.
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|
| Intra-procedural |
| Modified First Pass Reperfusion Effect (mFPE) | The number of subjects with mTICI ≥ 2b 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 Day 5-7 or discharge whichever occurs earlier) |
| İstanbul Aydın Üniversitesi V.M Medical Park Florya Hastanesi |
| Istanbul |
| Turkey (Türkiye) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |