Observational Study of Zoom System for Stroke
This observational study is looking at how well and how safely a treatment called the Zoom System with Continuous Dual Aspiration Technique (CDAT) works for people experiencing an acute ischemic stroke (a type of stroke caused by a blood clot). This technique helps remove blood clots from the brain. Researchers want to see if this treatment can effectively open up blood vessels and if it causes any new blockages. You might be able to join if you are at least 18 years old, had a good quality of life before your stroke, and are undergoing or have recently undergone this specific aspiration thrombectomy procedure. The study aims to include 750 participants, but its current status is unclear.
- Study design
- This is an observational study that plans to include 750 participants. It is designed to evaluate the effectiveness, safety, and clinical performance of the Zoom System with Continuous Dual Aspiration Technique (CDAT).
- What's involved
- You or your legally authorized representative must provide written informed consent before any study-specific procedures, or no later than 72 hours after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured at the end of the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Continuous Dual Aspiration Technique With Zoom System for Stroke
At a glance
Conditions
Where it's being run
17 sites across 13 statesStudy leadership
- David Fiorella, MD · PRINCIPAL_INVESTIGATOR · Stony Brook University Hospital
- Shahram Majidi, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- Justin Masciteli, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
- Maxim Mokin, MD · PRINCIPAL_INVESTIGATOR · University of South Florida
Who to contact
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What this trial measures
- Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-labEnd of procedure
mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (\<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches
- Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessmentEnd of procedure
Embolization to New Territory (ENT), defined as the presence of new occlusions on final angiography that occur in vascular territories remote from those effected by index stroke, as assessed by the investigator