Coarctation of the Aorta Stent Trial (COAST)
The study is a prospective, multi-center, single-arm clinical study comparing stent treatment of native or recurrent aortic coarctation to surgery. Surgical comparisons are derived from retrospective data collection at selected participating centers and from the literature.
A total of 130 patients will be enrolled in this study, with 95 expected to have placement of a CP stent and complete the study. The study will be conducted at 20 sites, with Johns Hopkins as the main site and the data coordinating center located at Children[Right Quote]s Hospital, Boston. Locally, at Children[Right Quote]s Medical Center and UT Southwestern, we expect to enroll 10 participants over the 2 year enrollment period with 3 expected screen failures/early withdrawals and 7 completing the study. The participants will be followed for up to 64 months after placement of the stent. The entire study will take up to 7 years to complete. Participants will receive a $50 gift card at the time of the 12 and 24 month follow up visits to help with travel expenses.
The study is designed to compare primary efficacy and safety outcomes in patients treated with CP bare metal stents against data from surgical treatment to determine whether non-surgical, aortic stent placement is as safe as surgical repair. Assessment and classification of stent placement will be done by analyzing the angiographic images of each participant at the Core Laboratory. In addition, over the course of the study adverse events will be recorded and classified regarding the likelihood of their relationship to the stent. For certain anticipated adverse events including aortic injury, stent malposition, and stent fracture, further classification will be done. This information is required to establish the safety and efficacy of the CP stent and to move towards FDA approval of expandable bare metal and covered stents for use in the non-surgical treatment of coarctation of the aorta and other congenital heart defects that may benefit from placement of an aortic stent.
Male and female subjects, age 8 to 60 years of all racial and ethnic origins including English and Spanish speaking patients who meet the following criteria:
Precatheterization Inclusion Criteria:
a. Native or recurrent aortic coarctation
b. weight greater than or equal to 35 kg
c. Noninvasive, arm-leg cuff systolic blood pressure* difference or catheter measure systolic coarcation gradient of greater than or equal to 20 mmHg
* Patient receiving antihypertensive therapy can be included in the study. The type and dose of the medication will be recorded and used for comparisons with follow up evaluations.
Catheterization Inclusion Criteria:
a. Coarctation of the aorta, either native or recurrent that is demonstrated, angiographically to involve the aortic isthmus or first segment of the descending aorta
b. Coarctation of the aorta found to be compliant on pre-stent balloon dilation
c. Patency of at least one femoral artery.