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The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.
The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).
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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 occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulseTM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of First Pass Reperfusion Effect (FPE) | The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass | Intra-procedural |
| Rate of symptomatic intracranial hemorrhage (sICH) | The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy | Post-procedural (24 hours post-thrombectomy) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reperfusion after all study device passes | Proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes with Study Device | Intra-procedural |
| Modified Rankin Scale (mRS) at 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt | Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass | Intra-procedural |
| Final reperfusion effect |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Yang | Contact | 9498367402 | cyang@rapidpulsemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Raul G Nogueira, MD | University of Pittsburgh Medical Center Stroke Institute | Principal Investigator |
| Marc Ribó, MD | Hospital Universitari Vall d' Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint John's Medical Foundation | Recruiting | Torrance | California | 90503 | United States |
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|
|
Proportion of patients who achieve mRS ≤2 at 90-days post treatment.
| Post-procedure (90 days post-thrombectomy) |
Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion
| Intra-procedural |
| Time to reperfusion | Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment. | Intra-procedural |
| Rate of major early neurological recovery | Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of at least 8 points or reaching NIHSS 0-1. *NIHSS ranges from 0 to 42, with higher scores indicating greater neurological deficit. | Post-procedure (24 hours post-thrombectomy) |
| Incidence of Serious Adverse Events (SAEs) | All device-related and procedure-related serious adverse events | Intra-procedural to post-procedure (through 90 days post-thrombectomy) |
| Incidence of all cause mortality | All-cause mortality assessed through 90 days post index procedure. | Intra-procedural to post-procedure (through 90 days post-thrombectomy) |
| Incidence of device related vasospasm | Device-related vasospasm | Intra-procedural |
| Incidence of embolism in new territory | Embolism in new territory determined based on procedural angiogram | Intra-procedural |
| Incidence of all intracranial hemorrhage | Any intracranial hemorrhage according to the Heidelberg classification at 24-hours | Post-procedural (24 hours post-thrombectomy) |
| Yale University | Not yet recruiting | New Haven | Connecticut | 06519 | United States |
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| Baptist Health Research Institute | Recruiting | Jacksonville | Florida | 32207 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33620 | United States |
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| Emory University at Grady | Recruiting | Atlanta | Georgia | 30303 | United States |
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| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Advocate Aurora Research Institute | Not yet recruiting | Park Ridge | Illinois | 60068 | United States |
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| Indiana University Health | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
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| State University of Iowa | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
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| Washington University | Not yet recruiting | St Louis | Missouri | 63110 | United States |
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| Cooper Health System | Not yet recruiting | Camden | New Jersey | 08103 | United States |
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| State University of New York at Buffalo | Recruiting | Buffalo | New York | 14203 | United States |
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| Icahn School of Medicine at Mount Sinai | Not yet recruiting | New York | New York | 10029 | United States |
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| UPMC | Active, not recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Prisma Health | Withdrawn | Greenville | South Carolina | 29601 | United States |
| Semmes Murphey Foundation - Baptist Memorial Hospital | Not yet recruiting | Memphis | Tennessee | 38120 | United States |
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| Vanderbilt University Medical Center | Withdrawn | Nashville | Tennessee | 37232 | United States |
| Valley Baptist Medical Center - Harlingen | Recruiting | Harlingen | Texas | 78550 | United States |
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| Centre Hospitalier Universitaire de Bordeaux | Not yet recruiting | Bordeaux | 33000 | France |
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| Centre Hospitalier Universitaire de Montpellier | Not yet recruiting | Montpellier | 34295 | France |
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| Centre Hospitalier Universitaire de Toulouse | Not yet recruiting | Toulouse | 31059 | France |
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| Hospital General Universitario Dr. Balmis | Recruiting | Alicante | 03010 | Spain |
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| Hospital Universitari Germans Trias i Pujol | Recruiting | Badalona | 08916 | Spain |
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| Hospital Universitari Vall d' Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitari de Bellvitge | Recruiting | Barcelona | 08907 | Spain |
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| Hospital Universitari de Girona Dr. Josep Trueta | Not yet recruiting | Girona | 17007 | Spain |
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| Hospital Universitario de la Princesa | Recruiting | Madrid | 28006 | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi | Recruiting | Istanbul | 34295 | Turkey (Türkiye) |
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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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular 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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