Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device for Cerebral Ischemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cerebral IschemiaImmediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether patients with a certain type of stroke do better with a medical procedure than with initial medical management.

Eligible Conditions
  • Cerebral Ischemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: 96 hours

24 hours post randomization
Infarct volume
Number of patients with early Neurologic Deterioration (END) comparing the two treatment arms
36 hours
Symptomatic intracranial hemorrhage (sICH) within 36 hours comparing the two treatment arms
90-day
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis).
Health-related quality of life EQ-5D score comparing the two treatment arms
Instrumental Activities of Daily Living (IADL)
Mortality rate within 90 days comparing the two treatment arms
Number of patients with excellent outcome comparing the two treatment arms arms
Number of patients with good outcome comparing the two treatment arms
Number of patients with intracranial hemorrhages using the Heidelberg Bleeding definition comparing the two treatment arms
Self-reported PROMIS Fatigue score
Self-reported mental and physical health PROMIS Global-10 score
Shift in distribution of the 90-day mRS with levels 5-6 combined (0;1;2;3;4;5-6) comparing the two treatment arms
96 hours
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Initial medical management (iMM)
1 of 2
Immediate mechanical thrombectomy(iMT)
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device · No Placebo Group · Phase 2 & 3

Immediate mechanical thrombectomy(iMT)Experimental Group · 2 Interventions: Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device, Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device · Intervention Types: Device, Device
Initial medical management (iMM)
CombinationProduct
ActiveComparator Group · 1 Intervention: Initial medical management (iMM) · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 96 hours

Who is running the clinical trial?

University of CalgaryOTHER
706 Previous Clinical Trials
493,521 Total Patients Enrolled
Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,705,806 Total Patients Enrolled
University of CincinnatiOTHER
389 Previous Clinical Trials
635,539 Total Patients Enrolled
Heidelberg UniversityOTHER
372 Previous Clinical Trials
224,647 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
758 Previous Clinical Trials
5,421,063 Total Patients Enrolled
Raul G Nogueira, MDPrincipal InvestigatorEmory University
15 Previous Clinical Trials
353,267 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between the ages of 18 and 50 years.
On CTA: Occlusion of both branches after MCA division (both M2s occluded) or occlusion of the larger diameter M2 branch
The bulk (>2/3) of the MCA territory has evidence of delayed washout on multiphase CT or ii.
You have a stroke and you have an objective neurological deficit.
Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.