Print

Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject is ≥ 18 years of age 2. 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 3. Pre-stroke mRS 0-2 4. 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

  1. Subjects with a life expectancy of less than 6 months 2. Female subject who is known to be pregnant at time of admission 3. Any intracranial hemorrhage in the qualifying head CT or MRI 4. 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.). 5. In the opinion of the Investigator, the patient is not a suitable candidate for intervention with the Zoom System 6. 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
ADAPT 2.0: Zoom System with Continuous Dual Aspiration Technique (CDAT) The Zoom System is intended to be used as the first-line device and utilized within the FDA-cleared indications for use, consistent with the approved labeling and intended anatomical targets.
  • Device: Zoom System
    Aspiration neurothrombectomy using Zoom System with Continuous Dual Aspiration Technique (CDAT)
    Other names:
    • ADAPT 2.0
    • Aspiration thrombectomy for stroke
    • Continuous dual aspiration
    • Neurovascular aspiration thrombectomy

Recruiting Locations

Huntsville Hospital
Huntsville, Alabama 35801
Contact:
Farrar Hickey

More Details

Status
Recruiting
Sponsor
Imperative Care, Inc.

Study Contact

Pojai Phattanagosai
650-740-7703
pphattanagosai@Imperativecare.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.