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 24, 2026
Study Type
OBSERVATIONAL
Conditions
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(10)
View Full Details on ClinicalTrials.gov
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NCT07491952
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