RapidPulse Aspiration System for Stroke

(PIVOTAL Trial)

Recruiting at 32 trial locations

Overseen By Cynthia Yang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RapidPulse, Inc

Disqualifiers: Intracranial hemorrhage, ICAD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Intra-procedural

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the RapidPulse Aspiration System for treating individuals experiencing an acute ischemic stroke. The treatment involves a procedure called mechanical thrombectomy, which removes a blockage in the brain to restore blood flow. This trial suits those who have experienced a stroke with severe symptoms within the past 8 hours and can begin treatment promptly. Participants will engage in the study for 90 days. As an unphased trial, this study allows participants to contribute to important research that could enhance stroke treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RapidPulseTM Aspiration System is safe for stroke patients?

Studies have shown that the RapidPulseTM Aspiration System effectively and safely treats strokes caused by large blood clots. Research indicates that this system successfully reopens blocked blood vessels in the brain, restoring blood flow safely. Early data from previous studies suggest it is well-tolerated by patients.

In these studies, complications were rare and usually mild, so most people did not experience serious side effects. The system employs a procedure called mechanical thrombectomy, which removes the clot to restore blood flow.

Overall, initial findings suggest the RapidPulseTM Aspiration System is safe for treating sudden strokes caused by blocked blood vessels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for acute ischemic stroke, which often involve medication or traditional mechanical thrombectomy tools, the RapidPulse Aspiration System uses an innovative aspiration technique to remove blood clots. This method directly targets and removes the thrombus (blood clot) from the brain's blood vessels, potentially offering a faster and more effective solution. Researchers are excited about this treatment because it could improve patient outcomes by swiftly restoring blood flow, thereby minimizing brain damage and enhancing recovery chances.

What evidence suggests that the RapidPulseTM Aspiration System is effective for acute ischemic stroke?

Research has shown that the RapidPulseTM Aspiration System effectively treats sudden strokes caused by blocked blood flow in the brain. This system removes the clots responsible for these blockages. Early data indicates it is safe and successful in reopening blocked blood vessels. In this trial, participants will undergo a procedure called mechanical thrombectomy, using the RapidPulseTM Aspiration System to remove clots and restore blood flow. These initial findings suggest that RapidPulseTM offers a promising way to improve recovery in stroke patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Raul G Nogueira, MD

Principal Investigator

University of Pittsburgh Medical Center Stroke Institute

Marc Ribó, MD

Principal Investigator

Hospital Universitari Vall d' Hebron

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who've had a stroke within the last 8 hours, with a significant blockage in major brain arteries. They should have an NIH Stroke Scale score of at least 6 and be able to start treatment within two hours after imaging. A good health status before the stroke (mRS score 0-1) is required.

Inclusion Criteria

Pre-morbid Modified Rankin Scale (mRS) score 0-1

I have had a stroke and my condition is serious.

I can start treatment within 8 hours of my first symptoms or from when I last felt normal.

Exclusion Criteria

Alberta Stroke Program Early CT Score (ASPECTS) <6

Multiple or tandem occlusions

Life expectancy less than 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo mechanical thrombectomy using the RapidPulseTM Aspiration System

Intra-procedural

1 visit (in-person)

Postoperative Assessment

Postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RapidPulseTM Aspiration System

Trial Overview The RapidPulseTM Aspiration System is being tested for its safety and effectiveness in removing blood clots from the brain during mechanical thrombectomy in acute ischemic stroke patients. The study will follow participants for three months.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

RapidPulse, Inc

Lead Sponsor

Trials

4

Recruited

270+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571368/

RapidpulseTM cyclic aspiration system for acute ischemic ... Conclusion. Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions. Keywords: ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38515399/

Rapidpulse TM cyclic aspiration system for acute ischemic ... Conclusion: Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05122637

Feasibility Study of RapidPulseTM Aspiration System as ... 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 ...

4. rapidpulsemed.com rapidpulsemed.com/clinical-trials

Clinical Trials The pivotal study of RapidPulse® as a frontline approach for patients with acute ischemic stroke due to large vessel occlusions.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15910199241239094

Rapidpulse TM cyclic aspiration system for acute ischemic ... Conclusion. Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

6. ahajournals.org ahajournals.org/doi/10.1161/str.54.suppl_1.WMP96

Abstract WMP96: A Prospective Trial Of The RapidpulseTm ... Introduction: First-pass effect (FPE) is associated with improved clinical outcomes and reduced mortality in mechanical thrombectomy (MT) ...