The Pivotal Study of RapidPulseTM Aspiration System

ID#: NCT06029491

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: March 27, 2025

End Date: December 01, 2026

Contact Information:
Cynthia Yang
9498367402
Summary: 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.
Eligibility:

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
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