Recruiting

ADAPT 2.0

Sponsor:

Imperative Care, Inc.

Code:

NCT07491952

Conditions

Ischemic Stroke

Acute Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zoom System

Study Details

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

Study ID

NCT07491952

Start date

Mar 24, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Zoom System

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

Primary outcome measure

  • 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 ]
  • Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment [ Time Frame: End of procedure ]

Central Contacts and Locations

Central contacts

Pojai Phattanagosai

650-740-7703pphattanagosai@Imperativecare.com

Emma Pham

408-421-7684epham@imperativecare.com

Locations

Huntsville Hospital

Recruiting

Huntsville, Alabama, United States, 35801

Principal Investigator:

R. Dana Tomalty, MD

John Muir Health

Recruiting

Walnut Creek, California, United States, 94598

Principal Investigator:

Benjamin Yim, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Principal Investigator:

Maxim Mokin, MD

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Principal Investigator:

James Milburn, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Jacob Cherian, MD

Allina Health

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Collin Torok, MD

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Principal Investigator:

Alexandra Paul, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Michael T Caton, MD

University of Oklahoma, Health Science Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator:

Hakeem Shakir, MD

Prisma Health - Upstate

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

Jan Vargas Machaj, MD

Semmes Murphey Foundation

Recruiting

Memphis, Tennessee, United States, 38120

Principal Investigator:

Lucas Elijovich, MD

HCA Houston Healthcare Kingwood

Recruiting

Kingwood, Texas, United States, 77339

Principal Investigator:

Mohamad Ezzeldin, MD

Methodist Healthcare System of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Lee Birnbaum, MD

University of Texas Science Health Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Justin Mascitelli, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Robert Rennert, MD

Inova Fairfax Medical Campus

Recruiting

Falls Church, Virginia, United States, 22042

Principal Investigator:

James McEachern, MD

More Information

Sponsor

Imperative Care, Inc.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Imperative Care, Inc. on 2026-08-07.