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Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

2014-08-27 03:36:09 | BioPortfolio

Summary

The purposes of this study are:

1. To confirm the PROTÉGÉ ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device are safe and effective in the treatment of carotid artery stenosis for subjects with a high risk for complications during carotid endarterectomy.

2. To evaluate rare and unanticipated adverse events.

3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Study Design

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

Conditions

Carotid Artery Disease

Intervention

PROTÉGÉ ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device

Location

William Beaumont
Royal Oak
Michigan
United States

Status

Recruiting

Source

ev3 Endovascular, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:36:09-0400

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Vascular filters or occlusive devices that provide mechanical protection of the distal end organ from blood clots or EMBOLISM-causing debri dislodged during ENDOVASCULAR PROCEDURES.

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The two principal arteries supplying the structures of the head and neck. They ascend in the neck, one on each side, and at the level of the upper border of the thyroid cartilage, each divides into two branches, the external (CAROTID ARTERY, EXTERNAL) and internal (CAROTID ARTERY, INTERNAL) carotid arteries.

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