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Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

2014-07-23 21:12:45 | BioPortfolio

Summary

The primary objective is to evaluate the safety and efficacy of the Large Diameter Advanta™ V12 Covered Stent for treatment of coarctation of the aorta in selected children, adolescents and adults.

Efficacy success will be defined as a significant reduction in the gradient across the coarctation as assessed pre stent versus immediately post stent and pre stent versus 12 month follow-up in two values from the Doppler echocardiographic profile: DV (diastolic velocity in cm/sec) and DV/SV (diastolic velocity/systolic velocity ratio).

The safety endpoint will be achieving a morbidity rate that is non-inferior to the OPC (Objective Performance Criteria) rate for surgery reported in Carr [23].

MAEs (Major Adverse Events) and MAVEs (Major Adverse Vascular Events) contributing to the morbidity rate include listing adverse events and complications.

The secondary efficacy endpoint: An increase in the diameter of the coarctation after stent placement such that the diameter of the coarctation will be ≥ 80% of diameter of the transverse arch immediately distal to the left Subclavian artery (CoA:DAo ≥ 0.8) after the stenting procedure and maintain this increased diameter over a 12 month period.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coarctation of the Aorta

Intervention

Large Diameter Advanta™ V12 Covered Stent

Location

Hospital for Sick Children Labatt Family Heart Centre
Toronto
Ontario
Canada
M5G 1X8

Status

Recruiting

Source

Atrium Medical Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:45-0400

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Medical and Biotech [MESH] Definitions

A birth defect characterized by the narrowing of the AORTA that can be of varying degree and at any point from the transverse arch to the iliac bifurcation. Aortic coarctation causes arterial HYPERTENSION before the point of narrowing and arterial HYPOTENSION beyond the narrowed portion.

The portion of the descending aorta proceeding from the arch of the aorta and extending to the DIAPHRAGM, eventually connecting to the ABDOMINAL AORTA.

The aorta from the DIAPHRAGM to the bifurcation into the right and left common iliac arteries.

Either of two large arteries originating from the abdominal aorta; they supply blood to the pelvis, abdominal wall and legs.

An abnormal balloon- or sac-like dilatation in the wall of the THORACIC AORTA. This proximal descending portion of aorta gives rise to the visceral and the parietal branches above the aortic hiatus at the diaphragm.

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