The Pivotal Study of RapidPulseTM Aspiration System (PIVOTAL)

RapidPulse

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Device: RapidPulseTM Aspiration System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06029491

CIP-0002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.

Treatment:

Device: RapidPulseTM Aspiration System