Recent Updates
Recently added Catalysts

Endovascular Treatment

Phase 1

Acute Stroke | Unknown | Neurology |Stryker Corporation|Last Updated: Feb 5, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
Double-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02618031The Capillary Index Score TrialPHASE1 COMPLETED 57Mar 1, 2016Dec 31, 2018Feb 5, 20206 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
90 days

The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6).

Secondary Endpoints
Complication Rate Between Favorable CIS Group Versus Poor CIS Group
1 day - 1 week
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.
90 days
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Favorable CISOTHERPatients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Poor CISEXPERIMENTALPatients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Interventions
NameTypeDescription
Endovascular Treatment (EVT)PROCEDUREEVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA (tissue plasminogen activator) directly at the site of the clot. The protocol calls for use of the Trevo stent retriever (Stryker Neurovascular) for the first pass of clot removal.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1) 2. Within 24 hours of onset of symptoms 3. NIHSS Score is 8 or greater Exclusion Criteria: 1. Contra-indication for IAT found on initial CT ...

Countries:United States
Unlock Eligibility Criteria