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NCT Number: NCT07491952

Continuous Dual Aspiration Technique With Zoom System for Stroke

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).

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Key information

Conditions

Ischemic Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntsville Hospital, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoom System

Device

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

Primary outcomes

  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

    Time frame: End of procedure

    mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches

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

    Time frame: End of procedure

    Embolization to New Territory (ENT), defined as the presence of new occlusions on final angiography that occur in vascular territories remote from those effected by index stroke, as assessed by the investigator

Secondary outcomes

  1. Time to achieve mTICI≥2c, defined as groin puncture to investigator assessment for mTICI≥2c

    Time frame: Intraprocedural

    The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2c using study device and technique.

    mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches

  2. Proportion of cases with clot ingestion, as evidenced by clot captured within the Zoom POD

    Time frame: Intraprocedural

    Proportion of cases with clot ingestion, as evidenced by clot captured within at least one of the Zoom PODs

  3. Proportion of cases with clot captured within the Zoom POD connected to the outer aspiration catheter

    Time frame: Intraprocedural

    Proportion of cases with clot ingestion, as evidenced by clot captured within the outer Zoom PODs

  4. Rate of rescue therapy

    Time frame: Intraprocedural

    Proportion of cases with rescue therapy, defined as unplanned use of another manufacturer's thrombectomy device, angioplasty, or stenting within the target vessel territory to achieve mTICI≥2c.

  5. Rate of functional independence (mRS 0-2) at 90 days

    Time frame: 90 days post-procedure

    Proportion of patients achieving mRS (modified Rankin Scale) ≤2 at 90 days

    mRS range: 0 to 6; The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death; higher score means worse outcome

  6. Proportion of patients achieving First Pass Effect (FPE) mTICI ≥2c as adjudicated by independent core-lab

    Time frame: Intraprocedural

    Proportion of cases achieving First Pass Effect (FPE), defined as mTICI ≥2c after the first pass with the study device and technique as adjudicated by independent core-lab

    mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches

  7. 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

    Independently adjudicated rate of symptomatic intracranial hemorrhage (sICH) defined as any apparently extravascular blood in the brain or within the cranium confirmed by imaging that is associated with clinical deterioration as defined by an increase of four or more points in the NIHSS at 24 hours compared to the baseline assessment, or that led to death, and was judged to be the predominant cause of a neurologic deterioration or death, per ECASS III criteria

  8. 90-day all-cause mortality

    Time frame: 90 days post-procedure

    Rate of all-cause mortality through 90 days post-procedure

  9. Rate of device-related Serious Adverse Events, independently adjudicated medical monitor

    Time frame: Intraprocedural

    Independently adjudicated rate of Serious Adverse Events related to study device

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Pham

CONTACT

[email protected]

408-421-7684

Pojai Phattanagosai

CONTACT

[email protected]

650-740-7703

Sponsors and collaborators

Lead sponsor

Imperative Care, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Continuous Dual Aspiration Technique With Zoom System for Stroke (ADAPT 2.0)

Acronym: ADAPT 2 0

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 25, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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