Continuous Dual Aspiration with the Zoom System for Acute Ischemic Stroke

Clinical Evaluation of Continuous Dual Aspiration Technique With Zoom System for Stroke (ADAPT 2.0)

This trial will try using the Zoom aspiration system with a continuous dual aspiration technique to remove clots in adults with acute ischemic stroke.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Imperative Care, Inc. (industry)
• Locations: 9 sites (Huntsville, Alabama and 8 other locations)
• Trial ID: NCT07491952 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with acute ischemic stroke due to a single occlusion who have pre-stroke mRS 0–2 and are treated first-line with the Zoom System using CDAT are the intended participants.

Not a fit: Patients with intracranial hemorrhage, tandem or multiple occlusions, known pregnancy, life expectancy under six months, or those deemed unsuitable by the investigator are excluded and unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the technique could increase complete reperfusion rates and shorten procedure times, which may lead to better functional recovery for patients.

How similar studies have performed: Previous ADAPT-style aspiration-first techniques have demonstrated favorable reperfusion outcomes, but continuous dual aspiration with the Zoom System is a newer approach with limited published data.

Eligibility criteria

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 this trial is running

Huntsville, Alabama and 8 other locations

• 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)
• University of Maryland — Baltimore, Maryland, United States (RECRUITING)
• Allina Health — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
• Albany Medical College — Albany, New York, United States (RECRUITING)
• Prisma Health - Upstate — Greenville, South Carolina, United States (RECRUITING)
• Semmes Murphey Foundation — Memphis, Tennessee, United States (NOT_YET_RECRUITING)
• University of Texas Science Health Center at San Antonio — San Antonio, Texas, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: David Fiorella, MD — Stony Brook University Hospital
• Study coordinator: Pojai Phattanagosai

Conditions: Ischemic Stroke, Acute Stroke, stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS