NCT00552812

Coarctation Of the Aorta Stent Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Richard E. Ringel · Academic / Other
• Sex: All
• Age: 8 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.

Detailed description

The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures. The aims of the Phase One study are to assess the use of the CP bare metal stent to: 1. provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient; 2. accomplish gradient relief with a shorter number of days in hospital than surgery; 3. accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and 4. accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.

Conditions

• Coarctation of the Aorta

Interventions

Type	Name	Description
DEVICE	Stent therapy of aortic coarctation	Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-12-01
• Completion: 2015-07-01
• First posted: 2007-11-02
• Last updated: 2016-03-11
• Results posted: 2014-09-25

Locations

1 site across 1 country: United States