PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorIndiana University
About this trial
Investigators are conducting a real world, observational, prospective, multicenter study to better understand treatment for patients with MeVo and distal vessel occlusions in the U.S post publication of recent MeVO trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute ischemic stroke clinically eligible for immediate EVT
Age ≥18 - 85 years of age
Time from onset (or last-seen-well) to 24 hours
Confirmed treatable MeVO based on neurovascular non-invasive imaging (CTA or MRA), at one or more of the following locations: M2 or M3 segment, A2 or A3 segment, P1, P2 or P3 segment
Disqualifiers
Age >86
ASPECTS ≤ 5
Any intracranial hemorrhage on initial CT head non contrast
mRS≥3
Trial population
Ischemic Stroke
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
652 Participants
are grouped into 2 trial groupsGroup A: Endovascular Treatment
Group B: Medical Management
Trial outcomes
Primary outcomes
1
Clinical outcomes based on distribution of modified Rankin Scale score(mRS)
The modified Rankin Scale (a 7-point scoring system, 0 indicates no residual stroke symptoms and 6 represents death) is assessed through patient/caregiver interview by trained personnel.
Time frame
3 months +/- 15 daysSecondary outcomes
1
Utility weighted Modified Rankin scale (mRS) at 90 days
The Utility-Weighted Modified Rankin Scale (UW-mRS) is an advancement in the assessment of disability and functional independence for patients with neurological conditions. By incorporating patient preferences, it complements the traditional Modified Rankin Scale (mRS) by capturing individual preferences for specific health states.
Time frame
3 months +/- 15 days2
Excellent functional recovery (mRS 0-1)
Excellent functional recovery (mRS 0-1): Functional independence is identified by pooling all patients achieving a) no stroke deficits (mRS of 0), b)minimal stroke deficits without any functional limitations (mRS of 1)
Time frame
3 months +/- 15 days3
Functional independence (mRS 0-2)
Functional independence is identified by pooling all patients achieving a) no stroke deficits (mRS of 0), b) minimal stroke deficits without any functional limitations (mRS of 1) and c) functional limitations that do not interfere with independent living (mRS of 2) and illustrates being able to execute all day to day activities.
Time frame
3 months +/- 15 daysOther outcomes
1
Symptomatic intracranial hemorrhage (sICH):
Symptomatic Intracerebral Hemorrhage (sICH) is defined using ECASS III criteria. (The ECASS III definition of symptomatic intracranial hemorrhage was any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by 4 points or more than the value at baseline or the lowest value in the first 7 days, or any hemorrhage leading to death. In addition, the hemorrhage must have been identified as the predominant cause of the neurological deterioration.)
Time frame
24 hours +/- 6 hours2
Mortality
death by the time of study completion
Time frame
1 year3
Intracranial hemorrhage post treatment
Heidelberg classification will be used to classify all post treatment intracranial hemorrhage.
Time frame
24 hours +/- 6 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
phenox Inc.
Collaborator
Source ClinicalTrials.gov