RecruitingNCT07491952

Continuous Dual Aspiration Technique With Zoom System for Stroke

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

Sponsor

Imperative Care, Inc.

Enrollment

750 participants

Start Date

Mar 31, 2026

Study Type

OBSERVATIONAL

Conditions

Acute Stroke Ischemic Stroke

Summary

This study is designed to evaluate the effectiveness, safety and clinical performance of ADAPT 2.0, first-line aspiration neurothrombectomy with Zoom System with Continuous Dual Aspiration Technique (CDAT).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Subject is ≥ 18 years of age
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
Pre-stroke mRS 0-2
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 Criteria6

Subjects with a life expectancy of less than 6 months
Female subject who is known to be pregnant at time of admission
Any intracranial hemorrhage in the qualifying head CT or MRI
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.).
In the opinion of the Investigator, the patient is not a suitable candidate for intervention with the Zoom System
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

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Interventions

DEVICEZoom System

Aspiration neurothrombectomy using Zoom System with Continuous Dual Aspiration Technique (CDAT)

Locations(7)

Huntsville Hospital

Huntsville, Alabama, United States

John Muir Health

Walnut Creek, California, United States

University of South Florida

Tampa, Florida, United States

Albany Medical College

Albany, New York, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Semmes Murphey Foundation

Memphis, Tennessee, United States

University of Texas Science Health Center at San Antonio

San Antonio, Texas, United States

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NCT07491952

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