Acute Stroke, Ischemic Stroke
Conditions
Keywords
stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS, ADAPT, continuous, dual aspiration, Zoom System
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).
Interventions
DEVICEZoom System
Aspiration neurothrombectomy using Zoom System with Continuous Dual Aspiration Technique (CDAT)
Sponsors
Imperative Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-lab | End of procedure | 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 |
| Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment | End of procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve mTICI≥2c, defined as groin puncture to investigator assessment for mTICI≥2c | Intraprocedural | 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 |
| Proportion of cases with clot ingestion, as evidenced by clot captured within the Zoom POD | Intraprocedural | Proportion of cases with clot ingestion, as evidenced by clot captured within at least one of the Zoom PODs |
| Proportion of cases with clot captured within the Zoom POD connected to the outer aspiration catheter | Intraprocedural | Proportion of cases with clot ingestion, as evidenced by clot captured within the outer Zoom PODs |
| Rate of rescue therapy | Intraprocedural | 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. |
| Rate of functional independence (mRS 0-2) at 90 days | 90 days post-procedure | 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 |
| Proportion of patients achieving First Pass Effect (FPE) mTICI ≥2c as adjudicated by independent core-lab | Intraprocedural | 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 |
| Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging and independently adjudicated by medical monitor, at the 24-hour post-procedure | 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 |
| 90-day all-cause mortality | 90 days post-procedure | Rate of all-cause mortality through 90 days post-procedure |
| Rate of device-related Serious Adverse Events, independently adjudicated medical monitor | Intraprocedural | Independently adjudicated rate of Serious Adverse Events related to study device |
Countries
United States
Contacts
CONTACTPojai Phattanagosai
CONTACTEmma Pham
PRINCIPAL_INVESTIGATORDavid Fiorella, MD
Stony Brook University Hospital
PRINCIPAL_INVESTIGATORShahram Majidi, MD
Icahn School of Medicine at Mount Sinai
PRINCIPAL_INVESTIGATORJustin Masciteli, MD
The University of Texas Health Science Center at San Antonio
PRINCIPAL_INVESTIGATORMaxim Mokin, MD
University of South Florida
Outcome results
None listed