The Pivotal Study of RapidPulseTM Aspiration System

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 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
• 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)

Other trials for the same condition