Continuous Dual Aspiration Technique With Zoom System for Stroke

N/ARecruitingNCT07491952

Imperative Care, Inc.750 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

750

Conditions

Ischemic Stroke Acute Stroke

Interventions

Zoom SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Huntsville Hospital

Huntsville, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Central Contacts

Pojai Phattanagosai

CONTACT

650-740-7703 pphattanagosai@Imperativecare.com

Emma Pham

CONTACT

408-421-7684 epham@imperativecare.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

John Muir Health

Walnut Creek, California, United States

RECRUITING

University of South Florida

Tampa, Florida, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

RECRUITING

University of Maryland

Baltimore, Maryland, United States

RECRUITING

Allina Health

Minneapolis, Minnesota, United States

RECRUITING

Albany Medical College

Albany, New York, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

NOT_YET_RECRUITING

University of Oklahoma, Health Science Center

Oklahoma City, Oklahoma, United States

RECRUITING

...and 7 more locations

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 90 days post-procedure

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

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

90-day all-cause mortality

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

Time frame: 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

Time frame: Intraprocedural