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The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System

2014-08-27 03:38:01 | BioPortfolio

Summary

The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.

Description

The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.

Study Design

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

Conditions

Intracranial Aneurysm

Intervention

Vascular Reconstruction Device

Location

Université Libre de Bruxelles
Bruxelles
Belgium
1070

Status

Active, not recruiting

Source

Codman & Shurtleff

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:01-0400

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