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).
Brief Title
Continuous Dual Aspiration Technique With Zoom System for Stroke
Central Contacts
Central Contact Role
Contact
Central Contact Phone
650-740-7703
Central Contact Email
pphattanagosai@Imperativecare.com
Central Contact Role
Contact
Central Contact Phone
408-421-7684
Central Contact Email
epham@imperativecare.com
Completion Date
Completion Date Type
Estimated
Conditions
ISCHEMIC STROKE
ACUTE STROKE
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
stroke
thrombectomy
Zoom
aspiration
reperfusion
mRS
ADAPT
continuous
dual aspiration
Zoom System
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07491952
Org Class
Industry
Org Full Name
Imperative Care, Inc.
Org Study Id
ICI-2025-003
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Clinical Evaluation of Continuous Dual Aspiration Technique With Zoom System for Stroke (ADAPT 2.0)
Primary Outcomes
Outcome Description
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
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
Outcome Time Frame
End of procedure
Outcome Description
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
Outcome Measure
Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment
Outcome Time Frame
End of procedure
Secondary Outcomes
Outcome Description
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
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
Outcome Time Frame
Intraprocedural
Outcome Measure
Time to achieve mTICI≥2c, defined as groin puncture to investigator assessment for mTICI≥2c
Outcome Description
Proportion of cases with clot ingestion, as evidenced by clot captured within at least one of the Zoom PODs
Outcome Time Frame
Intraprocedural
Outcome Measure
Proportion of cases with clot ingestion, as evidenced by clot captured within the Zoom POD
Outcome Description
Proportion of cases with clot ingestion, as evidenced by clot captured within the outer Zoom PODs
Outcome Time Frame
Intraprocedural
Outcome Measure
Proportion of cases with clot captured within the Zoom POD connected to the outer aspiration catheter
Outcome Description
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.
Outcome Time Frame
Intraprocedural
Outcome Measure
Rate of rescue therapy
Outcome Description
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
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
Outcome Time Frame
90 days post-procedure
Outcome Measure
Rate of functional independence (mRS 0-2) at 90 days
Outcome Description
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
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
Outcome Time Frame
Intraprocedural
Outcome Measure
Proportion of patients achieving First Pass Effect (FPE) mTICI ≥2c as adjudicated by independent core-lab
Outcome Description
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
Outcome Time Frame
24-hour post-procedure
Outcome Measure
Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging and independently adjudicated by medical monitor, at the 24-hour post-procedure
Outcome Description
Rate of all-cause mortality through 90 days post-procedure
Outcome Time Frame
90 days post-procedure
Outcome Measure
90-day all-cause mortality
Outcome Description
Independently adjudicated rate of Serious Adverse Events related to study device
Outcome Time Frame
Intraprocedural
Outcome Measure
Rate of device-related Serious Adverse Events, independently adjudicated medical monitor
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adult subjects with acute ischemic stroke secondary to large vessel occlusion (LVO) meeting the study eligibility criteria and providing written informed consent.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Amanda Baker
Investigator Department
Radiology
Investigator Division
Neuroradiology
Investigator Sponsor Organization
External
Study Department
Radiology
Study Division
Neuroradiology
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- ISCHEMIC STROKE
Brain, Spinal Cord & Nervous System --- STROKE
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ISCHEMIC STROKE
STROKE
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
THROMBECTOMY
VASCULAR SURGICAL PROCEDURES
CARDIOVASCULAR SURGICAL PROCEDURES
SURGICAL PROCEDURES, OPERATIVE