Continuous Dual Aspiration Technique With Zoom System for Stroke (ADAPT 2 0)

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).

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Acute Stroke
• Intervention / Treatment: Device: Zoom System

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Pojai Phattanagosai; Phone Number: 650-740-7703; Email: pphattanagosai@Imperativecare.com
• Study Contact Backup: Name: Emma Pham; Phone Number: 408-421-7684; Email: epham@imperativecare.com

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Huntsville Hospital
      • Contact: Farrar Hickey
      • Principal Investigator: R. Dana Tomalty, MD
  • California
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • John Muir Health
      • Principal Investigator: Benjamin Yim, MD
      • Contact: Melenie Aaron
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Principal Investigator: Maxim Mokin, MD
      • Contact: Kilaun Robinson
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Principal Investigator: Jacob Cherian, MD
      • Contact: Katie Henry
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Allina Health
      • Contact: Emeryth Beloy
      • Principal Investigator: Collin Torok, MD
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical College
      • Principal Investigator: Alexandra Paul, MD
      • Contact: Chelsey Large
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Kevin Buttet
      • Principal Investigator: Michael T Caton, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health - Upstate
      • Contact: Shawn Manos
      • Principal Investigator: Jan Vargas Machaj, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Semmes Murphey Foundation
      • Principal Investigator: Lucas Elijovich, MD
      • Contact: Wendell Barnett
  • Texas
    • Kingwood, Texas, United States, 77339
      • Not yet recruiting
      • HCA Houston Healthcare Kingwood
      • Principal Investigator: Mohamad Ezzeldin, MD
      • Contact: Kelechi Ibezim
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • Methodist Healthcare System of San Antonio
      • Contact: Samantha Franklin
      • Principal Investigator: Lee Birnbaum, MD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Science Health Center at San Antonio
      • Principal Investigator: Justin Mascitelli, MD
      • Contact: Athena Lazaris-Conner
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Not yet recruiting
      • Inova Fairfax Medical Campus
      • Contact: Lauren Monroe
      • Principal Investigator: James McEachern, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraprocedural
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	Intraprocedural
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	Intraprocedural
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.	Intraprocedural
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	Intraprocedural
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	24-hour post-procedure
90-day all-cause mortality	Rate of all-cause mortality through 90 days post-procedure	90 days post-procedure
Rate of device-related Serious Adverse Events, independently adjudicated medical monitor	Independently adjudicated rate of Serious Adverse Events related to study device	Intraprocedural
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	90 days post-procedure

Collaborators and Investigators

• Sponsor: Imperative Care, Inc.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stroke; reperfusion; aspiration; thrombectomy; continuous; mRS; ADAPT; Zoom; dual aspiration; Zoom System
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Thrombectomy
• Other Study ID Numbers: ICI-2025-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No