NCT06029491

The Pivotal Study of RapidPulseTM Aspiration System

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: RapidPulse, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	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 RapidPulseTM 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.

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2023-09-08
• Last updated: 2025-12-22

Locations

30 sites across 4 countries: United States, France, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated device study