NCT06029491 The Pivotal Study of RapidPulseTM Aspiration System
| NCT ID | NCT06029491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RapidPulse, Inc |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2025-03-27 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Raul G Nogueira, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh Medical Center Stroke Institute
Frequently Asked Questions
Who can join the NCT06029491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06029491 currently recruiting?
Yes, NCT06029491 is actively recruiting participants. Contact the research team at cyang@rapidpulsemed.com for enrollment information.
Where is the NCT06029491 trial being conducted?
This trial is being conducted at Torrance, United States, New Haven, United States, Jacksonville, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT06029491 clinical trial?
NCT06029491 is sponsored by RapidPulse, Inc. The principal investigator is Raul G Nogueira, MD at University of Pittsburgh Medical Center Stroke Institute. The trial plans to enroll 170 participants.
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