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Ischemic StrokeADAPT 2 0NCT07491952

Continuous Dual Aspiration Technique With Zoom System for Stroke

An observational study of Ischemic Stroke and Acute Stroke, run by Imperative Care, Inc. at 25 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Acute Stroke
What is being tested?
Zoom System
Type of treatment
Medical device
How many people
750 participants
Where
25 sitesUnited States
Study dates
24 Mar 2026to 1 Jun 2030
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pojai Phattanagosai contact

650-740-7703

pphattanagosai@Imperativecare.com

Emma Pham contact

408-421-7684

epham@imperativecare.com

25 sites in 1 country

United States25 sites, 25 recruiting

  • Albany Medical College

    Albany, New York, 12208

    Chelsey Large

    Alexandra Paul, MD

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Katie Henry

    Jacob Cherian, MD

    Recruiting

  • University at Buffalo Neurosurgery

    Buffalo, New York, 14203

    Ellen Carl

    Jason Davies, MD

    Recruiting

  • TriHealth Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Mehnaaz Ali

    Andrew Ringer, MD

    Recruiting

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

    Lauren Monroe

    James McEachern, MD

    Recruiting

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605

    Shawn Manos

    Jan Vargas Machaj, MD

    Recruiting

  • Huntsville Hospital

    Huntsville, Alabama, 35801

    Farrar Hickey

    R. Dana Tomalty, MD

    Recruiting

  • HCA Houston Healthcare Kingwood

    Kingwood, Texas, 77339

    Kelechi Ibezim

    Mohamad Ezzeldin, MD

    Recruiting

  • Fort Sanders Regional Medical Center

    Knoxville, Tennessee, 37902

    Cameron Carter

    Robert Hixson, MD

    Recruiting

  • Ochsner Clinic Foundation (Lafayette)

    Lafayette, Louisiana, 70503

    Shail Thanki, MD

    Recruiting

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

    Autumn Lee

    Ahmad Khaldi, MD

    Recruiting

  • Semmes Murphey Foundation

    Memphis, Tennessee, 38120

    Wendell Barnett

    Lucas Elijovich, MD

    Recruiting

  • Allina Health

    Minneapolis, Minnesota, 55407

    Emeryth Beloy

    Collin Torok, MD

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Jessica Henry

    James Milburn, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Kevin Buttet

    Michael T Caton, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Hanah Hwang

    Amol Mehta, MD

    Recruiting

  • University of Oklahoma, Health Science Center

    Oklahoma City, Oklahoma, 73104

    Sanaa Hameed

    Hakeem Shakir, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Andrew Grandemange

    Robert Rennert, MD

    Recruiting

  • Methodist Healthcare System of San Antonio

    San Antonio, Texas, 78229

    Samantha Franklin

    Lee Birnbaum, MD

    Recruiting

  • University of Texas Science Health Center at San Antonio

    San Antonio, Texas, 78229

    Athena Lazaris-Conner

    Justin Mascitelli, MD

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

    Kyle Kramer

    Christopher Zylak, MD

    Recruiting

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

    Saptarshi Prachi

    Haydn Hoffman, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Kilaun Robinson

    Maxim Mokin, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Genesis Liriano

    Amanda Baker, MD

    Recruiting

  • John Muir Health

    Walnut Creek, California, 94598

    Melenie Aaron

    Benjamin Yim, MD

    Recruiting

Other trials in United States

About this study

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

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).

Being tested
Zoom System
Keywords
stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS, ADAPT, continuous, dual aspiration, Zoom System
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoom SystemDevice

    Also called ADAPT 2.0, Aspiration thrombectomy for stroke, Continuous dual aspiration, Neurovascular aspiration thrombectomy

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

Study groups in NCT07491952
Study groupRoleWhat they receive
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.
Receives: Device: Zoom System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: End of procedure

Secondary outcomes (9)

  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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 24-hour post-procedure

  8. 90-day all-cause mortality

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

    Measured: 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

    Measured: Intraprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start24 Mar 2026
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07491952
Sponsor's protocol ID
ICI-2025-003
Acronym
ADAPT 2 0
Status last verified
Oct 2026
First submitted
17 Mar 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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