ClinicalTrials.gg
RecruitingNCT07491952ADAPT 2 0Updated Nov 6, 2026

Continuous Dual Aspiration Technique With Zoom System for Stroke

An observational study in Ischemic Stroke and Acute Stroke, sponsored by Imperative Care, Inc.. Recruiting at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Imperative Care, Inc. · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Updated Oct 20, 20264 sites addedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Ischemic Stroke
  • Acute Stroke

Keywords

  • stroke
  • thrombectomy
  • Zoom
  • aspiration
  • reperfusion
  • mRS
  • ADAPT
  • continuous
  • dual aspiration
  • Zoom System
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 750 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Imperative Care, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult subjects with acute ischemic stroke secondary to large vessel occlusion (LVO) meeting the study eligibility criteria and providing written informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is ≥ 18 years of age
  2. Subject or legally authorized representative has provided written 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 device within its intended use

Exclusion criteria

Exclusion Criteria:

  1. Subjects with a 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceZoom System

    Aspiration neurothrombectomy using Zoom System with Continuous Dual Aspiration Technique (CDAT)

    Also known as: ADAPT 2.0, Aspiration thrombectomy for stroke, Continuous dual aspiration, Neurovascular aspiration thrombectomy

06

What researchers measure

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

    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

    Time frame: End of procedure

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

    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

    Time frame: End of procedure

Secondary outcomes

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

    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

    Time frame: Intraprocedural

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

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

    Time frame: Intraprocedural

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

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

    Time frame: Intraprocedural

  4. Rate of rescue therapy

    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.

    Time frame: Intraprocedural

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

    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

    Time frame: 90 days post-procedure

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

    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

    Time frame: Intraprocedural

  7. Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging and independently adjudicated by medical monitor, at the 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

    Time frame: 24-hour post-procedure

  8. 90-day all-cause mortality

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

    Time frame: 90 days post-procedure

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

    Independently adjudicated rate of Serious Adverse Events related to study device

    Time frame: Intraprocedural

07

Study locations

25 of 25 sites recruiting
  • Huntsville Hospital
    Huntsville, Alabama 35801, United States
    Recruiting
    • Farrar Hickey · Contact
    • R. Dana Tomalty, MD · Principal investigator
  • John Muir Health
    Walnut Creek, California 94598, United States
    Recruiting
    • Melenie Aaron · Contact
    • Benjamin Yim, MD · Principal investigator
  • University of South Florida
    Tampa, Florida 33606, United States
    Recruiting
    • Kilaun Robinson · Contact
    • Maxim Mokin, MD · Principal investigator
  • Wellstar Kennestone Hospital
    Marietta, Georgia 30060, United States
    Recruiting
    • Autumn Lee · Contact
    • Ahmad Khaldi, MD · Principal investigator
  • Ochsner Clinic Foundation (Lafayette)
    Lafayette, Louisiana 70503, United States
    Recruiting
    • Shail Thanki, MD · Principal investigator
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
    Recruiting
    • Jessica Henry · Contact
    • James Milburn, MD · Principal investigator
  • University of Maryland
    Baltimore, Maryland 21201, United States
    Recruiting
    • Katie Henry · Contact
    • Jacob Cherian, MD · Principal investigator
  • Allina Health
    Minneapolis, Minnesota 55407, United States
    Recruiting
    • Emeryth Beloy · Contact
    • Collin Torok, MD · Principal investigator
  • Albany Medical College
    Albany, New York 12208, United States
    Recruiting
    • Chelsey Large · Contact
    • Alexandra Paul, MD · Principal investigator
  • University at Buffalo Neurosurgery
    Buffalo, New York 14203, United States
    Recruiting
    • Ellen Carl · Contact
    • Jason Davies, MD · Principal investigator
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
    • Kevin Buttet · Contact
    • Michael T Caton, MD · Principal investigator
  • Weill Cornell Medicine
    New York, New York 10065, United States
    Recruiting
    • Hanah Hwang · Contact
    • Amol Mehta, MD · Principal investigator
  • SUNY Upstate Medical Center
    Syracuse, New York 13210, United States
    Recruiting
    • Saptarshi Prachi · Contact
    • Haydn Hoffman, MD · Principal investigator
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
    Recruiting
    • Genesis Liriano · Contact
    • Amanda Baker, MD · Principal investigator
  • TriHealth Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
    Recruiting
    • Mehnaaz Ali · Contact
    • Andrew Ringer, MD · Principal investigator
  • University of Oklahoma, Health Science Center
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
    • Sanaa Hameed · Contact
    • Hakeem Shakir, MD · Principal investigator
  • Prisma Health - Upstate
    Greenville, South Carolina 29605, United States
    Recruiting
    • Shawn Manos · Contact
    • Jan Vargas Machaj, MD · Principal investigator
  • Fort Sanders Regional Medical Center
    Knoxville, Tennessee 37902, United States
    Recruiting
    • Cameron Carter · Contact
    • Robert Hixson, MD · Principal investigator
  • Semmes Murphey Foundation
    Memphis, Tennessee 38120, United States
    Recruiting
    • Wendell Barnett · Contact
    • Lucas Elijovich, MD · Principal investigator
  • HCA Houston Healthcare Kingwood
    Kingwood, Texas 77339, United States
    Recruiting
    • Swathi Potla · Contact
    • Mohamad Ezzeldin, MD · Principal investigator
  • Methodist Healthcare System of San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
    • Samantha Franklin · Contact
    • Lee Birnbaum, MD · Principal investigator
  • University of Texas Science Health Center at San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
    • Athena Lazaris-Conner · Contact
    • Justin Mascitelli, MD · Principal investigator
  • University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
    • Andrew Grandemange · Contact
    • Robert Rennert, MD · Principal investigator
  • Inova Fairfax Medical Campus
    Falls Church, Virginia 22042, United States
    Recruiting
    • Lauren Monroe · Contact
    • James McEachern, MD · Principal investigator
  • Providence Sacred Heart Medical Center and Children's Hospital
    Spokane, Washington 99204, United States
    Recruiting
    • Kyle Kramer · Contact
    • Christopher Zylak, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

4 registry updates since Sep 25, 2026
Sites
4 sites added
Show 4 added (4 United States)
  • University at Buffalo Neurosurgery · Buffalo, United States
  • SUNY Upstate Medical Center · Syracuse, United States
  • Weill Cornell Medicine · New York, United States
  • TriHealth Good Samaritan Hospital · Cincinnati, United States
across 3 updates, Sep 28, 2026 – Oct 20, 2026
Site contacts
Changed at 3 sites. See the sites
Show 3 sites
  • Wellstar Kennestone Hospital · Marietta, United StatesContact added (no phone or email listed)
  • Providence Sacred Heart Medical Center and Children's Hospital · Spokane, United StatesContact added (no phone or email listed)
  • HCA Houston Healthcare Kingwood · Kingwood, United StatesContact person changed (no phone or email listed)
across 2 updates, Oct 20, 2026 – Nov 6, 2026
Show all 4 updates
  1. Nov 6, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • HCA Houston Healthcare Kingwood · Kingwood, United StatesContact person changed (no phone or email listed)
    + 1 other change: verification date
  2. Oct 20, 2026
    2 sites added
    Show 2 added (2 United States)
    • Weill Cornell Medicine · New York, United States
    • TriHealth Good Samaritan Hospital · Cincinnati, United States
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Wellstar Kennestone Hospital · Marietta, United StatesContact added (no phone or email listed)
    • Providence Sacred Heart Medical Center and Children's Hospital · Spokane, United StatesContact added (no phone or email listed)
  3. Oct 9, 2026
    1 site added
    Show site
    • SUNY Upstate Medical Center · Syracuse, United States
    + 1 other change: verification date
  4. Sep 28, 2026
    1 site added
    Show site
    • University at Buffalo Neurosurgery · Buffalo, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07491952
Lead sponsor
Imperative Care, Inc.
Responsible party
Sponsor
First posted
Mar 25, 2026
Start date
Mar 24, 2026
Primary completion
Mar 31, 2030 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Pojai Phattanagosai
Contact
pphattanagosai@Imperativecare.com
650-740-7703
Emma Pham
Contact
epham@imperativecare.com
408-421-7684
David Fiorella, MD
principal investigator · Stony Brook University Hospital
Shahram Majidi, MD
principal investigator · Icahn School of Medicine at Mount Sinai
Justin Masciteli, MD
principal investigator · The University of Texas Health Science Center at San Antonio
Maxim Mokin, MD
principal investigator · University of South Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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