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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Covered Cheatham Platinum Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

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.

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


Original Primary Outcome:

  • 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.



Current Secondary Outcome:

  • 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.



Original Secondary Outcome:

  • 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.



Information By: Johns Hopkins University

Dates:
Date Received: August 2, 2010
Date Started: July 2010
Date Completion:
Last Updated: February 15, 2016
Last Verified: February 2016