Health TrialsbyHealthPanel

Continuous Dual Aspiration Technique With Zoom System for Stroke

ConditionsIschemic StrokeAcute Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperative Care, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥ 18 years of age

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

Pre-stroke mRS 0-2

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

Disqualifiers

Subjects with a life expectancy of less than 6 months

Female subject who is known to be pregnant at time of admission

Any intracranial hemorrhage in the qualifying head CT or MRI

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.).

Trial population

Adult subjects with acute ischemic stroke secondary to large vessel occlusion (LVO) meeting the study eligibility criteria and providing written informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Zoom System

    Device

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

Treatment groups

750 Participants
are divided into 1 treatment group
Group A: ADAPT 2.0: Zoom System with Continuous Dual Aspiration Technique (CDAT)1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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

Time frame
Intraprocedural
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperative Care, Inc.

Lead sponsor

Source ClinicalTrials.gov
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