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

This study has been completed.
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 15, 2016
Last verified: February 2016
  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.

Funding Source-FDA OOPD


Condition Intervention Phase
Aortic Coarctation
Device: Treatment of Aortic Wall Injury
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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

    C3

    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


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

    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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 82
Study Start Date: July 2010
Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment of Aortic Wall Injury
Repair of aortic wall injury with covered CP Stents
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.

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:   Child, Adult, Senior
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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Rady Children's Hospital and Health Center
San Diego, California, United States, 92123
University of California, San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Children's Hospital of New York - Presbyterian
New York, New York, United States, 10032
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital and Regional Medical Center, Seattle
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Richard E. Ringel
Harvard University
Investigators
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
  More Information

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
Results First Received: April 8, 2015
Last Updated: February 15, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Individual patient data is confidential and not shared.

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 December 02, 2016