Continuous Dual Aspiration Technique With Zoom System for Stroke (NCT07491952) | Clinical Trial Compass
RecruitingNot Applicable
Continuous Dual Aspiration Technique With Zoom System for Stroke
United States750 participantsStarted 2026-03-24
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a specific mechanical technique called 'Continuous Dual Aspiration' using the Zoom system for removing clots during a stroke — how does this compare to the clot-removal approach my care team would use for me under standard treatment?
2The trial is measuring whether patients achieve a score called mTICI ≥2c, which reflects how well blood flow is restored — can you explain what that score means for brain recovery, and how often current standard techniques achieve it?
3One of the key safety signals being tracked is whether the procedure accidentally sends clot material to new areas of the brain, called Embolization to New Territory — how common is that risk with existing approaches, and what would happen if it occurred during this procedure?
4Since this trial is listed as Phase NA, which I understand may mean it's evaluating a device or technique rather than a drug in a traditional phase structure — what does that mean for how much is already known about the safety and effectiveness of this specific system?
5Given that acute stroke treatment decisions often have to happen very quickly, how much time would I or my family realistically have to understand and agree to participate in this trial before the procedure would need to start?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-lab
Timeframe: End of procedure
2
Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment