Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

Completed · Phase 2

Conditions studied: Aortic Coarctation

In brief

Coarctation of the aorta (CoA) is a congenital abnormality producing obstruction to blood flow through the aorta. Coarctation can occur in isolation, in association with bicuspid aortic valve or with major cardiac malformations. CoA accounts for 5-8% of the 8/1000 (4-6/10,000) children born with congenital heart disease. Most CoA is newly diagnosed in childhood; \< 25% recognized beyond 10 yrs. CoA is mostly repaired in childhood by surgery or by balloon catheter dilation. Recurrence rates range from 5-20%. Recurrence is often not recognized until adolescence. Balloon expandable stents have become the predominant therapy in the USA and Europe for CoA treatment in this age group. There are no FDA approved stents for this use. Biliary stents are currently being used off label. Enrollment into a trial of bare metal Cheatham Platinum (CP) Stents, designed for use in CoA, is completed. The Coarctation of the Aorta Stent Trial (COAST) aims to confirm safety and efficacy of CP Stent for native and recurrent CoA. There are CoA patients with clinical situations that place them at high risk of aortic wall injury during bare metal stenting. Extreme narrowing, genetic aortic wall weakness and advanced age are examples. Patients may present with aortic wall injury (aneurysm) related to prior CoA repair. The occurrence after surgical repair is 3-4% and after balloon dilation 10-20%. Repair of these aneurysms is surgically challenging. The use of fabric-covered CP Stents to prevent or repair aortic wall injury has become the treatment of choice in Europe and recently in the US through the FDA Compassionate Use process. There are no alternative devices available in the US. COAST II will test safety and efficacy of Covered CP Stents to repair or prevent aortic wall injury associated with CoA. Funding Source-FDA OOPD

Key facts

Study ID

NCT01278303

Run by

Johns Hopkins University

People needed

82

Starts

2010-07-01

Expected to finish

2014-12-01

Last updated by the study team

2023-04-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patient size too small for safe delivery of the device. The absolute lower limit for inclusion under this protocol is 20 kg. However, serious femoral artery injury can occur in small patients, particularly those in the 20-30 kg range and this risk must be reviewed in detail with parents or guardians of children in this weight range.
• Planned deployment diameter less than 10 mm or greater than 22 mm
• Location requiring covered stent placement across a carotid artery*
• Adults lacking capacity to consent
• Pregnancy
• crossing or covering of a subclavian artery is acceptable in certain situations, but only after alternative treatments have been considered.

Where it is running

• Rady Children's Hospital and Health Center — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Miami Children's Hospital — Miami, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Children's Hospital of New York - Presbyterian — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital and Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• Baylor College of Medicine, Texas Children's Hospital — Houston, Texas, United States
• Children's Hospital and Regional Medical Center, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.