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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 .
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Coarctation of the Aorta
Large Diameter Advanta™ V12 Covered Stent
Hospital for Sick Children Labatt Family Heart Centre
Atrium Medical Corporation
Published on BioPortfolio: 2014-07-23T21:12:45-0400
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Coarctation of the aorta (CoA) accounts for 4-8% of congenital heart defects (CHDs) and confers substantial morbidity despite treatment. It is increasingly recognized as a highly heritable condition. ...
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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.
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body. A stent is placed in an artery as part of a procedure called angioplasty. &...
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