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A Clinical Investigation to Evaluate and Compare the Safety and Efficacy of Using ZOOM Reperfusion Catheters and Stent Retrievers in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients

2019-10-21 12:45:20 | BioPortfolio

Summary

Prospective, randomized, open label, with blinded assessment (PROBE) to compare the rate of good functional outcomes at 90 days (mRS=0-2) following thrombectomy within 24 hours of stroke onset with either the Imperative Care ZOOM Reperfusion Catheter or stent retrievers.

Description

Prospective, randomized, open label, with blinded assessment (PROBE) to compare the rate of good functional outcomes at 90 days (mRS=0-2) following thrombectomy within 24 hours of stroke onset with either the Imperative Care ZOOM Reperfusion Catheter or stent retrievers.

Follow-up visits will occur at 24 hours, 3-7 days or discharge, and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.

Study Design

Conditions

Ischemic Stroke

Intervention

ZOOM Reperfusion Catheter, Trevo® Pro (Stryker) or Solitaire™ (Medtronic) Stent Retrievers

Status

Not yet recruiting

Source

Imperative Care, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:20-0400

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Medical and Biotech [MESH] Definitions

Adverse functional, metabolic, or structural changes in ischemic tissues resulting from the restoration of blood flow to the tissue (REPERFUSION), including swelling; HEMORRHAGE; NECROSIS; and damage from FREE RADICALS. The most common instance is MYOCARDIAL REPERFUSION INJURY.

Damage to the MYOCARDIUM resulting from MYOCARDIAL REPERFUSION (restoration of blood flow to ischemic areas of the HEART.) Reperfusion takes place when there is spontaneous thrombolysis, THROMBOLYTIC THERAPY, collateral flow from other coronary vascular beds, or reversal of vasospasm.

Generally, restoration of blood supply to heart tissue which is ischemic due to decrease in normal blood supply. The decrease may result from any source including atherosclerotic obstruction, narrowing of the artery, or surgical clamping. Reperfusion can be induced to treat ischemia. Methods include chemical dissolution of an occluding thrombus, administration of vasodilator drugs, angioplasty, catheterization, and artery bypass graft surgery. However, it is thought that reperfusion can itself further damage the ischemic tissue, causing MYOCARDIAL REPERFUSION INJURY.

Restoration of blood supply to tissue which is ischemic due to decrease in normal blood supply. The decrease may result from any source including atherosclerotic obstruction, narrowing of the artery, or surgical clamping. It is primarily a procedure for treating infarction or other ischemia, by enabling viable ischemic tissue to recover, thus limiting further necrosis. However, it is thought that reperfusion can itself further damage the ischemic tissue, causing REPERFUSION INJURY.

A hindrance to the passage of fluids through a CATHETER.

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