Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Rate of perfusion success using only the study device. — Intra-procedural
  The proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes where only aspiration with the Study Device was used without rescue, as assessed by an independent Imaging Core Lab.
• 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

Trial sites (30)

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