Recruiting NCT07491952
Continuous Dual Aspiration Technique With Zoom System for Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zoom System.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Acute Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Evaluation of Continuous Dual Aspiration Technique With Zoom System for Stroke (ADAPT 2.0)
Overview
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).
Interventions
- Device Zoom System
Aspiration neurothrombectomy using Zoom System with Continuous Dual Aspiration Technique (CDAT)
Primary outcome measures
- Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-lab [Time frame: End of procedure]
- Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment [Time frame: End of procedure]
Secondary outcome measures (9)
- Time to achieve mTICI≥2c, defined as groin puncture to investigator assessment for mTICI≥2c [Time frame: Intraprocedural]
- Proportion of cases with clot ingestion, as evidenced by clot captured within the Zoom POD [Time frame: Intraprocedural]
- Proportion of cases with clot captured within the Zoom POD connected to the outer aspiration catheter [Time frame: Intraprocedural]
- Rate of rescue therapy [Time frame: Intraprocedural]
- Rate of functional independence (mRS 0-2) at 90 days [Time frame: 90 days post-procedure]
- Proportion of patients achieving First Pass Effect (FPE) mTICI ≥2c as adjudicated by independent core-lab [Time frame: Intraprocedural]
- Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging and independently adjudicated by medical monitor, at the 24-hour post-procedure [Time frame: 24-hour post-procedure]
- 90-day all-cause mortality [Time frame: 90 days post-procedure]
- Rate of device-related Serious Adverse Events, independently adjudicated medical monitor [Time frame: Intraprocedural]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 17 centers
- Huntsville Hospital — Huntsville
- John Muir Health — Walnut Creek
- University of South Florida — Tampa
- Ochsner Clinic Foundation — New Orleans
- University of Maryland — Baltimore
- Allina Health — Minneapolis
- Albany Medical College — Albany
- Icahn School of Medicine at Mount Sinai — New York
- … and 9 more centers
Identifiers
NCT: NCT07491952 · ICI-2025-003