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

Study ID
STU 092010-091

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Sharon Kern
214-456-8755
sharon.kern@childrens.com

Principal Investigator
Thomas Zellers

Summary

This study is a prospective, nonrandomized, observational, multi-center (North America and Western Europe) study in which a comparison between surgery, balloon angioplasty and intravascular stent placement for native and recurrent coarctation is made. The hypothesis is that intravascular stent placement will be superior in the immediate and intermediate follow-up.
Patients who meet criteria will be enrolled if they meet the inclusion criteria of weight [AND]amp;gt;10 kg, presence of coarctation with a gradient [AND]amp;gt; 20 mmHg requiring therapy. The therapy will be at the discretion/preference of the cardiologist at the patient[Right Quote]s local institution; it will not be randomized.
Success will be defined as a residual gradient [AND]amp;lt; 20 mmHg following intervention. Failure will be defined as a residual gradient [AND]amp;gt; 20 mmHg, occurrence of a serious complication, or death. Complications will be documented immediately and at scheduled follow-up.
Endpoints for each patient will be death or the patient reaching 60 months out from the initial procedure. Data reporting will be handled at the principal institution, Wayne State University in Detroit.

The study information collected, both during the procedure and during follow-up visits, is already collected per routine standard patient care. There are no extra study visits. The duration of the regular visit will not be lengthened because of the study.

Participant Eligibility

Patients >= 10 kg body weight
Presence of a significant coarctation as determined by an upper to lower extremity blood pressure gradient > 20 mmHg, decreased LV function (SF < 25%) or aortic insufficiency with an upper to lower extremity blood pressure gradient > 10 mmHg

Standard treatment would include surgical or transcatheter treatment of the coarctation segment

Patients with known or suspected arteritis will be analyzed separately

Patients who do not require other surgical procedures that would entail correction for the coarctation segment in the same setting