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The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

2014-07-23 21:46:16 | BioPortfolio

Summary

To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Description

This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Aneurysms

Intervention

Cordis Self Expanding Stent

Location

Azienda Ospedaliera
Milano
Italy
20162

Status

Completed

Source

Codman & Shurtleff

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:46:16-0400

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Medical and Biotech [MESH] Definitions

A sudden CARDIAC ARRHYTHMIA (e.g., VENTRICULAR FIBRILLATION) caused by a blunt, non-penetrating impact to the precordial region of chest wall. Commotio cordis often results in sudden death without prompt cardiopulmonary defibrillation.

A rare developmental defect in which the heart is abnormally located partially or totally outside the THORAX. It is the result of defective fusion of the anterior chest wall. Depending on the location of the heart, ectopia cordis can be thoracic, thoracoabdominal, abdominal, and cervical.

A localized bulging or dilatation in the muscle wall of a heart (MYOCARDIUM), usually in the LEFT VENTRICLE. Blood-filled aneurysms are dangerous because they may burst. Fibrous aneurysms interfere with the heart function through the loss of contractility. True aneurysm is bound by the vessel wall or cardiac wall. False aneurysms are HEMATOMA caused by myocardial rupture.

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Abnormal outpouching in the wall of intracranial blood vessels. Most common are the saccular (berry) aneurysms located at branch points in CIRCLE OF WILLIS at the base of the brain. Vessel rupture results in SUBARACHNOID HEMORRHAGE or INTRACRANIAL HEMORRHAGES. Giant aneurysms (>2.5 cm in diameter) may compress adjacent structures, including the OCULOMOTOR NERVE. (From Adams et al., Principles of Neurology, 6th ed, p841)

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