18 and older, any sex, with Ischemic Stroke or Acute Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion SuccessPrimary· Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Group
Value
95% CI
Zoom Reperfusion System
216
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety BoardPrimary· 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Group
Value
95% CI
Zoom Reperfusion System
5
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion SuccessPrimary· Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Group
Value
95% CI
Zoom Reperfusion System
177
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety BoardPrimary· 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Group
Value
95% CI
Zoom Reperfusion System
2
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion SuccessPrimary· Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Group
Value
95% CI
Zoom Reperfusion System
125
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety BoardPrimary· 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Group
Value
95% CI
Zoom Reperfusion System
1
ITT Cohort: Time to Achieve mTICI Score ≥ 2bSecondary· Intraprocedural
The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b
mTICI range: 0 to 3; higher score means better reperfusion
Group
Value
95% CI
Zoom Reperfusion System
19
13 – 30
ITT Cohort: Rate of mTICI Score 3 ReperfusionSecondary· Intraprocedural
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better reperfusion
Group
Value
95% CI
Zoom Reperfusion System
78
ITT Cohort: Rate of First Pass SuccessSecondary· Intraprocedural
Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device
mTICI range: 0 to 3; higher score means better outcome
Group
Value
95% CI
Zoom Reperfusion System
148
ITT Cohort: Rate of mTICI Score 2c ReperfusionSecondary· Intraprocedural
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better outcome
Group
Value
95% CI
Zoom Reperfusion System
147
ITT Cohort: Rate of Functional IndependenceSecondary· 90-days post-procedure
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors
The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death
Group
Value
95% CI
Zoom Reperfusion System
133
ITT Cohort: Quality of Life AssessmentSecondary· 90 days post-procedure
The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a t
Overall Recovery
Group
Value
95% CI
Zoom Reperfusion System
71.5
± 25.8
Strength
Group
Value
95% CI
Zoom Reperfusion System
71
± 27.9
Memory and Thinking
Group
Value
95% CI
Zoom Reperfusion System
79.9
± 21.9
Emotion
Group
Value
95% CI
Zoom Reperfusion System
78.9
± 17.9
Communication
Group
Value
95% CI
Zoom Reperfusion System
85
± 22.6
Activities of Daily Living or Instrumental Activities of Daily Living
Group
Value
95% CI
Zoom Reperfusion System
76.3
± 28.5
Mobility
Group
Value
95% CI
Zoom Reperfusion System
71.5
± 29.5
Hand Function
Group
Value
95% CI
Zoom Reperfusion System
68.9
± 36
Adverse events — posted to ClinicalTrials.gov
Time frame: Throughout 90 days post-procedure.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post
· Phase 3
· recruiting
NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)
· Phase 2
· recruiting
NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours
· Phase 2
· recruiting
NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke
· recruiting
NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants
· Phase 1
· recruiting
Other Imperative Care, Inc. trials
Trials by the same sponsor.
NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke
· recruiting
NCT06062329 — SYMPHONY-PE Study for Treatment of Pulmonary Embolism
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Imperative Care, Inc.
Last refreshed: 8 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04129125.