Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta
Condition: Aortic Coarctation
MeSH terms: Aortic Coarctation
Intervention: Treatment of Aortic Wall Injury
Intervention description: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Healthy volunteers: No
Keywords: Coarctation; 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
    

Eligibility criteria:

        Inclusion Criteria: Inclusion criteria for use of a Covered CP Stent:

        Native or recurrent aortic coarctation* associated with ONE OR MORE of the following:

          1. Acute or chronic aortic wall injury, or

          2. Nearly atretic descending aorta to 3 mm or less in diameter, or

          3. 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

               -  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:

          1. 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.

          2. Planned deployment diameter less than 10 mm or greater than 22 mm

          3. Location requiring covered stent placement across a carotid artery*

          4. Adults lacking capacity to consent

          5. Pregnancy

               -  crossing or covering of a subclavian artery is acceptable in certain situations,
                  but only after alternative treatments have been considered.