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

NCT01278303 | Completed Phase 2 Results DMC

• 2 other identifiers: G060057aRFD003898A
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

Aortic Coarctation

Keywords

Coarctation; Aorta

Outcome Measures

Primary Outcomes (1)

• Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening

  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

  Baseline and 12 months

Secondary Outcomes (2)

• Secondary Efficacy Outcomes - 1 Year

  1 years

• Secondary Safety Outcomes - Adverse Events

  2 years

Study Arms (1)

Treatment of Aortic Wall Injury

OTHER

Repair of aortic wall injury with covered CP Stents

Device: Treatment of Aortic Wall Injury

Interventions

Treatment of Aortic Wall Injury DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Native or recurrent aortic coarctation\* associated with ONE OR MORE of the following:
• Acute or chronic aortic wall injury, or
• Nearly atretic descending aorta to 3 mm or less in diameter, or
• 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

You may not qualify if:

• Planned deployment diameter less than 10 mm or greater than 22 mm
• Location requiring covered stent placement across a carotid artery\*
• Adults lacking capacity to consent
• Pregnancy
• crossing or covering of a subclavian artery is acceptable in certain situations, but only after alternative treatments have been considered.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Harvard University: collaborator

Study Sites (19)

Rady Children's Hospital and Health Center

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Children's Hospital of New York - Presbyterian

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine, Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Children's Hospital and Regional Medical Center, Seattle

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Holzer RJ, Gauvreau K, McEnaney K, Watanabe H, Ringel R. Long-Term Outcomes of the Coarctation of the Aorta Stent Trials. Circ Cardiovasc Interv. 2021 Jun;14(6):e010308. doi: 10.1161/CIRCINTERVENTIONS.120.010308. Epub 2021 May 27.

  PMID: 34039015 DERIVED

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Richard E. Ringel
• Organization: Johns Hopkins Hospital

rringel@jhmi.edu

410-614-6745

Study Officials

• 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

  Morgan Stanley Children's Hospital

  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 National 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

  University of Pittsburgh

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: January 17, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: April 11, 2023
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)