Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

Not yet recruiting

Phase N/A Results N/A

Trial Description

Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

Detailed Description

Stroke is an acute neurologic dysfunction of vascular origin with sudden or at least rapid occurrence of symptoms and signs corresponding to the involvement of focal areas in the brain.The two main types of stroke are ischemic and hemorrhagic.Thrombosis can form in the extracranial and intracranial arteries when the intima is roughened and plaque forms along the injured vessel.The endothelial injury permits platelets to adhere and aggregate, then coagulation is activated and thrombus develops at site of plaque.Blood flow through the extracranial and intracranial systems decreases, and the collateral circulation maintains function. When the compensatory mechanism of collateral circulation fails, perfusion is compromised, leading to decreased perfusion and cell death. Stroke is the third leading cause of death in the United States. Many people die each year from stroke in the United States.Stroke is the leading cause of serious, long-term disability in the United States. Nearly one fourth of strokes occur in people under the age of 65.High blood pressure is the most important risk factor for stroke. Intravenous recombinant tissue-type plasminogen activator is the only Food and Drug Administration approved treatment for acute ischemic stroke. Mechanical thrombectomy improves clinical outcomes in patients with acute ischemic stroke caused by a large vessel occlusion.There is no apparent benefit of intravenous thrombolysis to patients with ischemic stroke undergoing mechanical thrombectomy. The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

Conditions

Interventions

  • Mechanical Thrombectomy (Merci Retriever)Device
    Other Names: Penumbra system; TREVO; Solitaire
    Intervention Desc: mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption
    ARM 1: Kind: Experimental
    Label: mechanical thrombectomy
    Description: The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.

Outcomes

Type Measure Time Frame Safety Issue
Primary Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy 18 months
Secondary The patients will be undergoing NIHSS score 1 hour
Secondary The patients will be undergoing ASPECTS score 1 hour
Secondary The patients will be undergoing CT/CT angiography 2 hours

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