RapidPulse Aspiration System for Stroke

(PIVOTAL Trial)

Recruiting at 30 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

Trial Summary

What is the purpose of this trial?

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.

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.

How is the RapidPulse Aspiration System treatment for stroke different from other treatments?

The RapidPulse Aspiration System is unique because it likely involves a mechanical approach to removing blood clots in stroke patients, unlike traditional drug treatments like alteplase, which use medication to dissolve clots. This system may offer a more direct and potentially faster method to restore blood flow in the brain. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Code stroke. An attempt to shorten inhospital therapeutic delays. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Role of Bedside Preparation in Reducing "Door-to-Needle" Tissue-Type Plasminogen Activator (Alteplase) Administration Times and Association with Patient Outcomes. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the implementation of a rapid response treatment protocol for patients with acute onset stroke: can we increase the number of patients treated and shorten the time needed? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Timeliness of intravenous thrombolysis via telestroke in Georgia. [2016]