Home › Trials › NCT06029491

Testing the RapidPulseTM Aspiration System for treating acute ischemic stroke

The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions

Not applicable Interventional RapidPulse, Inc · NCT06029491

This study is testing a new device called the RapidPulseTM Aspiration System to see if it can safely and effectively help people with acute ischemic stroke caused by blocked blood vessels in the brain.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorRapidPulse, Inc Industry-sponsored
Locations30 sites (Torrance, California and 29 other locations)
Trial IDNCT06029491 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the RapidPulseTM Aspiration System in patients suffering from acute ischemic stroke due to large vessel occlusions. Participants will undergo a mechanical thrombectomy procedure within 8 hours of symptom onset, with assessments conducted at 24 hours and again at 90 days post-treatment. The study will enroll up to 340 subjects across 30 global sites, focusing on achieving optimal blood flow restoration in the brain. The primary endpoints include the effectiveness of the procedure and the safety profile regarding symptomatic intracranial hemorrhage.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a clinical diagnosis of acute ischemic stroke and a NIHSS score of 6 or higher, who can be treated within 8 hours of symptom onset.

Not a fit: Patients with intracranial hemorrhage, severe pre-existing conditions, or those with a life expectancy of less than 6 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve outcomes for patients experiencing acute ischemic stroke by enhancing clot removal efficiency.

How similar studies have performed: While this specific approach is novel, similar mechanical thrombectomy techniques have shown promise in previous studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18 to 80 years
* Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
* Able to be treated within 8 hours of symptom onset or last known normal (LKN)
* Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
* Pre-morbid Modified Rankin Scale (mRS) score 0-1
* Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
* Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)

Exclusion Criteria:

* Intracranial Hemorrhage (ICH)
* Alberta Stroke Program Early CT Score (ASPECTS) \<6
* Intracranial Atherosclerotic Disease (ICAD)
* Multiple or tandem occlusions
* Life expectancy less than 6 months

Where this trial is running

Torrance, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Ischemic StrokeStrokeLarge Vessel OcclusionMechanical ThrombectomyNeurovascular Intervention
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.