Trial results for the Zoom Reperfusion System in acute ischemic stroke were posted on 2025-08-08, demonstrating a core lab-adjudicated reperfusion success rate of 83.4% in the FDA Clearance Cohort, meeting the pre-specified performance goal.
Background
Acute ischemic stroke, caused by a blockage in a blood vessel supplying the brain, is a leading cause of long-term disability and mortality worldwide. Rapid and effective reperfusion, the restoration of blood flow to the affected brain tissue, is critical for improving patient outcomes. Mechanical thrombectomy, a procedure to physically remove the clot, has become a standard of care for eligible patients. Devices that can efficiently and safely achieve reperfusion are vital in this time-sensitive medical emergency, aiming to minimize brain damage and improve functional recovery. The Zoom Reperfusion System was developed to assist in thrombectomy procedures for acute ischemic stroke.
Trial design
This completed study, designated as Phase NA, enrolled 328 participants diagnosed with Ischemic Stroke and Acute Stroke. The trial assessed the safety and efficacy of the Zoom Reperfusion System when used in thrombectomy procedures within 8 hours of last known well. The primary objectives, as defined by FDA agreed performance goals, included evaluating the rate of reperfusion success and the rate of symptomatic intracranial hemorrhage (sICH).
Key results
The trial reported several key measurements and analyses for the Zoom Reperfusion System:
- FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success
- An event rate of 83.4% (95% CI: 78.0% to 88.0%) was observed, with a p-value of 0.0001 (Fisher Exact method). This met the FDA agreed performance goal for efficacy, which required the lower bound of the 95% CI to be >69%.
- In this cohort, 177 participants achieved reperfusion success.
- FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
- An event rate of 1.9% (95% CI: 0.6% to 4.4%) was observed. This met the FDA agreed performance goal for safety, which required the observed rate to be ≤6.0%.
- In this cohort, 2 participants experienced sICH.
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
- An event rate of 84.0% (95% CI: 78.0% to 89.0%) was observed, with a p-value of 0.0001 (Fisher Exact method).
- In this subset, 125 participants achieved reperfusion success.
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH)
- An event rate of 0.9% (95% CI: 0.1% to 3.4%) was observed.
- In this subset, 1 participant experienced sICH.
- ITT Cohort: Time to Achieve mTICI Score ≥ 2b
- A median time of 19 minutes was reported.
- ITT Cohort: Rate of Functional Independence
- 133 participants achieved functional independence.
- ITT Cohort: Quality of Life Assessment
- A mean score of 71.5 (Standard Deviation 25.8) was reported on a scale.
- All-cause mortality
- An event rate of 12.7% (95% CI: 8.5% to 16.7%) was observed, which was below the FDA agreed performance goal of ≤20.3%.
What this means
The results indicate that the Zoom Reperfusion System successfully met its pre-specified FDA performance goals for both efficacy and safety in patients undergoing thrombectomy for acute ischemic stroke. The high rates of reperfusion success, coupled with low rates of symptomatic intracranial hemorrhage, suggest that the system is an effective and safe tool for restoring blood flow to the brain. The reported median time to reperfusion and the rate of functional independence further support its potential to improve patient outcomes in this critical condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04129125, titled "The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System", were posted on 2025-08-08 on clinicaltrials.gov.