Continuous Dual Aspiration Technique With Zoom System for Stroke

NCT07491952 | Recruiting DMC FDA Device

• 1 other identifier: ICI-2025-003
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Ischemic Stroke; Acute Stroke

Keywords

stroke; thrombectomy; Zoom; aspiration; reperfusion; mRS; ADAPT; continuous; dual aspiration; Zoom System

Outcome Measures

Primary Outcomes (2)

• 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

  End of procedure

• 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

  End of procedure

Secondary Outcomes (9)

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

  Intraprocedural

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

  Intraprocedural

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

  Intraprocedural

• Rate of rescue therapy

  Intraprocedural

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

  90 days post-procedure

Study Arms (1)

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

Zoom System DEVICE

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

ADAPT 2.0: Zoom System with Continuous Dual Aspiration Technique (CDAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperative Care, Inc.: lead

Study Sites (10)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

RECRUITING

John Muir Health

Walnut Creek, California, 94598, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Allina Health

Minneapolis, Minnesota, 55407, United States

RECRUITING

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

Prisma Health - Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

NOT YET RECRUITING

University of Texas Science Health Center at San Antonio

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David Fiorella, MD

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

• Shahram Majidi, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Justin Masciteli, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Maxim Mokin, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pojai Phattanagosai

CONTACT

650-740-7703; pphattanagosai@Imperativecare.com

Emma Pham

CONTACT

408-421-7684; epham@imperativecare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)