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Endovascular Treatment

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

Double-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

Endovascular Treatment · 1 trial · 3 indications

Phase 1 1
NCT02618031The Capillary Index Score TrialAcute Stroke
COMPLETED57 Analytics
PHASE1COMPLETED
The Capillary Index Score Trial
Acute StrokeUnlock trial analytics

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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Endovascular Treatment

What is Endovascular Treatment used for in Acute Stroke?

Endovascular Treatment is an investigational therapy being studied for use in Acute Stroke, specifically in patients with Brain Ischemia and Ischemic Stroke. It is a controlled, double-blind intervention that was evaluated in a Phase 1 clinical trial in the United States. The treatment is not yet approved and remains in clinical development.

Who makes Endovascular Treatment?

Endovascular Treatment is being developed by Stryker Corporation, a medical technology company traded on the NYSE under the ticker SYK. Stryker is conducting clinical research on this therapy for Acute Stroke, including a completed Phase 1 trial in the United States.

What phase is Endovascular Treatment in?

Endovascular Treatment is in Phase 1 clinical development. A Phase 1 trial, known as The Capillary Index Score Trial, has been completed. The therapy is investigational and has not been approved by regulatory authorities. It is being studied for Acute Stroke and related ischemic conditions.

What clinical trials is Endovascular Treatment in?

Endovascular Treatment has been studied in one clinical trial, NCT02618031, titled The Capillary Index Score Trial. This Phase 1 study was completed and enrolled 57 participants with Acute Stroke, Brain Ischemia, or Ischemic Stroke. The trial was conducted in the United States and included adults aged 18 years and older.

Is Endovascular Treatment FDA approved?

Endovascular Treatment is not FDA approved. It is an investigational therapy that has completed a Phase 1 clinical trial for Acute Stroke. The therapy is still in clinical development, and its safety and efficacy have not been established for regulatory approval.