Text Size

Covered Cheatham Platinum CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (COASTII)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Richard E. Ringel, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01278303
First received: August 2, 2010
Last updated: February 3, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Aortic Coarctation
 Device: Cheatham Covered Platinum Stent
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Covered Cheatham Platinum Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Primary Efficacy Outcome base on Severity of Illness. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Primary Efficacy Outcome

    Improvement of aortic wall injury and/or aortic arch obstruction by a median increase of at least one grade from the pre-implantation baseline to the 12 month follow-up using the Severity of Illness Scale.


  • Safety Outcome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    Primary Safety Outcome

    Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.



Secondary Outcome Measures:
  • Secondary Efficacy Outcomes - 1 and 2 years [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]

    Secondary Efficacy Outcomes

    Reduction of arm-leg systolic blood pressure gradients to less than or equal to 15 mmHg, reduction of upper extremity blood pressure at one year compared to baseline, and for patients with aortic wall injury repair of the wall defect without significant residual endoleak on MRI or CT scanning at one year post implant.


  • Secondary Safety Outcomes - Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Secondary Safety Outcomes

    The proportions of patients experiencing any adverse event, any event related to the stent, any event related to the implant procedure, underlying cardiac or non cardiac disease, aortic wall injury, new aortic aneurysm formation within the region of covered CP Stent implantation post one-year, stent misplacement, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, stratified by seriousness.



Enrollment: 81
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Covered CP Stent Device: Cheatham Covered Platinum Stent
A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.

Detailed Description:

There are no prior trials of preventing or treating aortic injury associated with CoA and thus no basis for comparison. A single outcome assessment will not suffice since patients can receive a device for either indication. A 3-category Severity of Illness Scale (SIS) was developed based on clinical judgment of a panel of pediatric cardiologists and reviewed by a Data & Safety Monitoring Board (DSMB) and the FDA Office of Device Evaluation. Five levels of severity have been defined for each of the 3 illness categories, including: Upper extremity hypertension, Upper to lower extremity pressure difference, and Severity of aortic wall injury. The DSMB will assign a level of illness from the SIS for each patient at baseline and one year follow up. Improvement by at least one level will indicate clinical importance. Safety is evaluated by identifying adverse events and comparing their occurrence to surgical repair of CoA in similar age groups reported in the medical literature.

  Eligibility

Ages Eligible for Study:   8 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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+
  2. Nearly atretic descending aorta to 3 mm or less in diameter.
  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

  4. 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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278303

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Richard E. Ringel
Harvard University
Investigators
Principal Investigator: John Moore, MD Rady Children's Hospital
Principal Investigator: Evan Zahn, MD Miami Children's Hospital
Principal Investigator: Thomas Jones, MD Seattle Children's Hospital
Principal Investigator: Doff McElhinney, MD Children's Hospital Boston
Principal Investigator: Julie Vincent, MD Children's Hospital of New York - Presbyterian
Principal Investigator: Allison Cabalka, MD Mayo Clinic
Principal Investigator: Frank Ing, MD Baylor College of Medecine, Texas Children's Hospital
Principal Investigator: Thomas Forbes, MD Children's Hospital of Michigan
Principal Investigator: Jonathan Rome, MD Children's Hospital of Philadelphia
Principal Investigator: Michael Slack, MD Children's Research Institute
Principal Investigator: Phil Moore, MD University of California, San Francisco
Principal Investigator: Robert Beekman, MD Cincinnati Children's Hospital and Medical Center
Principal Investigator: Jacqueline Kreutzer, MD Children's Hospital of Pittsburgh of UPMC
Principal Investigator: Thomas Zellers, MD Children's Medical Center Dallas
Principal Investigator: Larry Latson, MD The Cleveland Clinic
Principal Investigator: John Rhodes, MD Duke University
Principal Investigator: Dennis Kim, MD Children's Healthcare of Atlanta
Principal Investigator: John Cheatham, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Richard E. Ringel, Associate Professor of Pediatrics, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01278303     History of Changes
Other Study ID Numbers: G060057a, RFD003898A
Study First Received: August 2, 2010
Last Updated: February 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Coarctation
Aorta

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013