Testing the RapidPulseTM Aspiration System for treating acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 85 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)
* Significant mass effect and/or midline shift
* Alberta Stroke Program Early CT Score (ASPECTS) \<6 or (PC-ASPECTS \<8 on CT angiography source images or DWI MRI for posterior circulation stroke)
* Intracranial Atherosclerotic Disease (ICAD)
* Multiple or tandem occlusions
* Life expectancy less than 6 months

Where it's running

• Providence Saint John's Medical Foundation
  Torrance, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Baptist Health Research Institute
  Jacksonville, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Emory University at Grady
  Atlanta, Georgia, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Raul G Nogueira, MD — University of Pittsburgh Medical Center Stroke Institute
• Study coordinator: Cynthia Yang
• Email: cyang@rapidpulsemed.com
• Phone: 9498367402

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.