Clinical Trial: Coarctation Of the Aorta Stent Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Coarctation Of the Aorta Stent Trial

Brief 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 Summary:

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.

Sponsor: Richard E. Ringel

Current Primary Outcome: Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months [ Time Frame: 12 months ]

Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)


Original Primary Outcome: Reduction of Arm-leg Systolic Blood Pressure Difference [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement [ Time Frame: Baseline and 12 months ]
    Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure > 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).
  • Systolic Blood Pressure, Difference Between Upper and Lower Extremities [ Time Frame: Baseline and 12 months ]
    Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.


Original Secondary Outcome:

Information By: Johns Hopkins University

Dates:
Date Received: October 31, 2007
Date Started: October 2007
Date Completion:
Last Updated: February 14, 2016
Last Verified: February 2016