The Pivotal Study of RapidPulseTM Aspiration System (PIVOTAL)

The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions

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.

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).

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.

The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulse TM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.

The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass as assessed by an independent Imaging Core Lab.

The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by CEC.

Proportion of patients who achieve mTICI ≥ 2b, based on the best mTICI score within a maximum of 3 passes where only aspiration with Study Device was used without rescue, as assessed by an independent Imaging Core Lab. The performance goal is 0.55.

The proportion of patients achieving FPE reperfusion as defined by mTICI ≥ 2c after one reperfusion attempt as assessed by independent Imaging Core Lab. The performance goal is 0.4547.

Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass as assessed by an independent Imaging Core lab.

Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion as assessed by independent Imaging Core Lab.

Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.

Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in NIHSS score from baseline of at least 8 points or reaching NIHSS 0-1.

Embolism in new territory determined based on procedural angiogram as assessed by an independent Imaging Core Lab.

Any intracranial hemorrhage according to the Heidelberg classification at 24-hours as assessed by an independent Imaging Core Lab.

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 90 days