Continuous Dual Aspiration with the Zoom System for Acute Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects data on adults treated with the Zoom System using a Continuous Dual Aspiration Technique (CDAT) as first-line thrombectomy for acute ischemic stroke. Sites will record procedural details, angiographic reperfusion, safety events, and clinical outcomes, with informed consent obtained before or within 72 hours after the procedure. Eligible patients are adults (≥18) with pre-stroke mRS 0–2 and no qualifying intracranial hemorrhage, while those with tandem or multiple occlusions, pregnancy, limited life expectancy, or judged unsuitable by the investigator are excluded. The multicenter design at three U.S. hospitals documents real-world device performance rather than randomizing treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. Subject or legally authorized representative has provided written informed consent prior to any study-specific procedures and no later than 72 hours after the index procedure
3. Pre-stroke mRS 0-2
4. Subject is undergoing or has undergone an aspiration thrombectomy using the Zoom System with Continuous Dual Aspiration Technique (CDAT) as the first line device within its intended use

Exclusion Criteria:

1. Subjects with a life expectancy of less than 6 months
2. Female subject who is known to be pregnant at time of admission
3. Any intracranial hemorrhage in the qualifying head CT or MRI
4. Presence of tandem internal carotid artery occlusion, multiple occlusion locations (e.g., cavernous ICA and M1, separate M2 occlusions, etc.), or occlusions in multiple territories (e.g., MCA and ACA, bilateral, etc.).
5. In the opinion of the Investigator, the patient is not a suitable candidate for intervention with the Zoom System
6. Subject is currently enrolled in or planned to be enrolled in any concurrent interventional study that may impact the safety or performance data collected in this study

Where it's running

• Huntsville Hospital
  Huntsville, Alabama, United States Recruiting
• John Muir Health
  Walnut Creek, California, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Wellstar Kennestone Hospital
  Marietta, Georgia, United States Recruiting
• Ochsner Clinic Foundation (Lafayette)
  Lafayette, Louisiana, United States Recruiting
• Ochsner Clinic Foundation
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: David Fiorella, MD — Stony Brook University Hospital
• Study coordinator: Pojai Phattanagosai
• Email: pphattanagosai@Imperativecare.com
• Phone: 650-740-7703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.