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 range18 Years

SexALL

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

What they're measuring

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

Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment

Timeframe: End of procedure

Trial details

NCT IDNCT07491952

SponsorImperative Care, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-03-31

Contact for this trial

Pojai Phattanagosai

650-740-7703 pphattanagosai@Imperativecare.com

View on ClinicalTrials.gov More Ischemic Stroke trials

Who can participate

Age range18 Years

SexALL

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

What they're measuring

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

Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment

Timeframe: End of procedure