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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01278303
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Information provided by (Responsible Party):

August 2, 2010
January 17, 2011
April 8, 2015
March 14, 2016
March 14, 2016
July 2010
December 2012   (Final data collection date for primary outcome measure)
Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening [ Time Frame: Baseline and 12 months ]

Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up

SIS is divided into 3 conditions & 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- > 159 mmHg or any hpn on >2 medications 3- 140-159 mmHg or elevated SBP on >2 medications 4- 130-139 mmHg or normal SBP on >2 medications 5- <130 mmHg on 0-2 meds

C2 Upper Extremity to Lower Extremity SBP difference 2- >59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- <15 mmHg


Aortic Wall Injury severity levels:

  1. Uncontained rupture or large aneurysm
  2. Contained rupture or stable large aneurysm
  3. Small contained rupture or moderate aneurysm
  4. Acute, but stable AWI or small aneurysm
  5. No injury or minor aortic wall irregularity not in need of treatment.

    • Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy
  • Primary Efficacy Outcome base on Severity of Illness. [ Time Frame: 12 months ]

    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 ]

    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.

Complete list of historical versions of study NCT01278303 on ClinicalTrials.gov Archive Site
  • Secondary Efficacy Outcomes - 1 Year [ Time Frame: 1 years ]

    Secondary Efficacy Outcomes

    At One Year: (A) Number of participants with arm-leg systolic blood pressure (SBP) differences <15 mmHg and (B) Number of participants with normal or only mildly elevated SBP, no more than mild arm-leg SBP, no clinically significant residual aortic wall injury AND no worsening in any of these three categories

  • Secondary Safety Outcomes - Adverse Events [ Time Frame: 2 years ]

    Secondary Safety Outcomes

    The proportion of patients experiencing any serious or somewhat serious adverse event related to the stent or implant procedure by 24 months follow up, such as: new aortic wall injury within the region of covered CP Stent implantation, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, arterial access site injury, bleeding, etc.

  • Secondary Efficacy Outcomes - 1 and 2 years [ Time Frame: 1-2 years ]

    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 ]

    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.

Not Provided
Not Provided
Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta
Covered Cheatham Platinum Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

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

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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Coarctation
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.
Treatment of Aortic Wall Injury
Repair of aortic wall injury with covered CP Stents
Intervention: Device: Treatment of Aortic Wall Injury
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2014
December 2012   (Final data collection date for primary outcome measure)

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, or
  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.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
RFD003898A ( Other Grant/Funding Number: Food and Drug Administration )
Not Provided
Plan to Share IPD: No
Plan Description: Individual patient data is confidential and not shared.
Richard E. Ringel, Johns Hopkins University
Richard E. Ringel
Harvard University
Principal Investigator: John Moore, MD Rady Children's Hospital
Principal Investigator: John F Rhodes, MD Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Principal Investigator: Thomas Jones, MD Seattle Children's Hospital
Principal Investigator: Lisa Bergersen, MD Boston Children’s Hospital
Principal Investigator: Julie A 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: Joshua Kanter, MD Children's Research Institute
Principal Investigator: Phil Moore, MD University of California, San Francisco
Principal Investigator: Russel Hirsch, MD Children's Hospital Medical Center, Cincinnati
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
Principal Investigator: Gregory A Fleming, MD Duke University
Johns Hopkins University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP