Covered Cheatham Platinum CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (COASTII)
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.
|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|
- 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 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.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|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.
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.
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||John Moore, MD||Rady Children's Hospital|
|Principal Investigator:||Darren Berman, MD||Miami Children's Hospital|
|Principal Investigator:||Thomas Jones, MD||Seattle Children's Hospital|
|Principal Investigator:||Lisa Bergersen, 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:||Henri Justino, 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:||Russel Hirsch, 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:||Lourdes Prieto, MD||The Cleveland Clinic|
|Principal Investigator:||Gregory Fleming, MD||Duke University|
|Principal Investigator:||Dennis Kim, MD||Children's Healthcare of Atlanta|
|Principal Investigator:||John Cheatham, MD||Nationwide Children's Hospital|