Aortic Coarctation Treatment Comparison Study

Comparison between Surgical vs. Balloon Angioplasty vs. Intravascular Stent Placement for Recurrent or Native Coarctation of the Aorta

Protocol Description

The purpose of this study is to prospectively compare the safety and efficacy of the three alternatives for treatment of coarctation of the aorta. The data collected during this study consists of clinical parameters which are routinely collected at time of clinic visit or during the procedure itself. The study will compare surgery, balloon dilation, and use of a stent to address the condition.

Eligibility Criteria

Patients meeting the following inclusion criteria will be approached for study entry: those who weigh 10 kg (about 22 pounds) or more, who are diagnosed with coarctation of the aorta requiring intervention and for whom no other cardiac surgical procedures are planned that would require surgical repair of the aortic arch narrowing at time of surgery.
Boys: All ages
Girls: All ages

Requirements

As an observational study, nothing changes in terms of the care that the patient will receive. No extra tests or extra visits are required beyond whichever procedure is used for treatment. However additional information about the patient’s specific procedure and outcome will be gathered and included in the study database.
Visits: None beyond normal care
Duration: Patient’s progress will be followed for approximately 5 years.

Status: Enrollment Closed

Source(s) of Support

Congenital Cardiovascular Interventional Study Consortium

Primary Investigator

Jacqueline Kreutzer, MD, FACC, FSCAI

Contact Information

For information, please contact:
David Groscost
412-864-8655