The Pivotal Study of RapidPulseTM Aspiration System

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT06029491
• Lead Sponsor: RapidPulse, Inc

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.

Detailed Description

The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of symptomatic intracranial hemorrhage (sICH)	Post-procedural (24 hours post-thrombectomy)	The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy
Rate of First Pass Reperfusion Effect (FPE)	Intra-procedural	The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass

Secondary Outcome Measures

Name	Time	Method
Rate of reperfusion after all study device passes	Intra-procedural	Proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes with Study Device
Modified Rankin Scale (mRS) at 90 days post treatment	Post-procedure (90 days post-thrombectomy)	Proportion of patients who achieve mRS ≤2 at 90-days post treatment.

Trial Locations

Locations (30)

Providence Saint John's Medical Foundation; 🇺🇸 Torrance, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Baptist Health Research Institute; 🇺🇸 Jacksonville, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Emory University at Grady; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Advocate Aurora Research Institute; 🇺🇸 Park Ridge, Illinois, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

State University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

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