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

Summary

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

Conditions

• Aortic Coarctation

Interventions

DEVICE

Treatment of Aortic Wall Injury

A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.

Sponsors & Collaborators

• Harvard University

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• John Moore, MD · Rady Children's Hospital

• John F Rhodes, MD · Nicklaus Children's Hospital f/k/a Miami Children's Hospital

• Thomas Jones, MD · Seattle Children's Hospital

• Lisa Bergersen, MD · Boston Children's Hospital

• Julie A Vincent, MD · Morgan Stanley Children's Hospital

• Allison Cabalka, MD · Mayo Clinic

• Henri Justino, MD · Baylor College of Medecine, Texas Children's Hospital

• Thomas Forbes, MD · Children's Hospital of Michigan

• Jonathan Rome, MD · Children's Hospital of Philadelphia

• Joshua Kanter, MD · Children's National Research Institute

• Phil Moore, MD · University of California, San Francisco

• Russel Hirsch, MD · Children's Hospital Medical Center, Cincinnati

• Jacqueline Kreutzer, MD · University of Pittsburgh

• Thomas Zellers, MD · Children's Medical Center Dallas

• Lourdes Prieto, MD · The Cleveland Clinic

• Gregory Fleming, MD · Duke University

• Dennis Kim, MD · Children's Healthcare of Atlanta

• John Cheatham, MD · Nationwide Children's Hospital

• Gregory A Fleming, MD · Duke University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2012-12-31

Completion

2014-12-31

Countries

• United States

Study Locations