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

Overview

Información sobre este estudio

The purpose of this study is to test the safety and effectiveness of Covered CP Stents to repair or prevent aortic wall injury associated with Coarctation of the Aorta (CoA). 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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria - Covered CP Stent:

Native or recurrent aortic coarctation*associated with ONE OR MORE of the following:
- Acute or chronic aortic wall injury; or
- Nearly atretic descending aorta to 3 mm or less in diameter; or
- Genetic Syndromes associated with aortic wall weakening. Individuals with genetic syndromes such as Marfan Syndrome, Turner's Syndrome or familial bicuspid aortic valve and ascending aortic aneurysm; or
- Advanced age. Men and woman aged 60 years or older.
The significance of aortic obstruction is left to the judgment of the participating investigator. indications might include mild resting aortic obstruction associated with:
- Exercise related upper extremity hypertension;
- Severe coarctation with multiple and/or large arterial collaterals;
- Single ventricle physiology Left ventricular dysfunction Ascending aortic aneurysm + Aortic wall injury might include:
  - Descending aortic aneurysm Descending aortic pseudo-aneurysm Contained aortic wall rupture Non-contained rupture of the aortic wall.

Exclusion Criteria:

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic	Estatus
Rochester, Minn. Investigador principal de Mayo Clinic Allison Cabalka, M.D.	Cerrado para la inscripción

Sede de Mayo Clinic

Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Allison Cabalka, M.D.

Cerrado para la inscripción

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