A Phase 2 interventional study of Treatment of Aortic Wall Injury in Aortic Coarctation, sponsored by Johns Hopkins University. Completed at 19 sites in United States. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 82 is above the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Inclusion criteria for use of a Covered CP Stent:
Native or recurrent aortic coarctation* associated with ONE OR MORE of the following:
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
indications might include mild resting aortic obstruction associated with:
Ascending aortic aneurysm
Exclusion Criteria:
Pregnancy
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.
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
Time frame: Baseline and 12 months
Secondary Efficacy Outcomes - 1 Year
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
Time frame: 1 years
Secondary Safety Outcomes - Adverse Events
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.
Time frame: 2 years
| Milestone | Treatment of Aortic Wall Injury |
|---|---|
| Started | 82 |
| Completed | 82 |
| Not completed | 0 |
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
| participants | Treatment of Aortic Wall Injury |
|---|---|
| Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening | 55 |
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
| participants | Treatment of Aortic Wall Injury |
|---|---|
| (A) arm-leg SBP difference <15 mmHg | 54 |
| (B) Good clinical status at 1 yr w/o worsening | 55 |
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.
| percentage of participants | Treatment of Aortic Wall Injury |
|---|---|
| Serious Adverse Events | 1.2 |
| Somewhat Serious Adverse Events | 11 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment of Aortic Wall Injury | — | 1/82 (1.2%) | 38/82 (46.3%) |
| Event | Treatment of Aortic Wall Injury |
|---|---|
| Aortic Wall InjuryCardiac disorders | 1/82 |
| Event | Treatment of Aortic Wall Injury |
|---|---|
| Bruising or HemorrhageBlood and lymphatic system disorders | 9/82 |
| Pain or DiscomfortGeneral disorders | 8/82 |
| Device SpecificCardiac disorders | 8/82 |
| Aortic Wall InjuryCardiac disorders | 4/82 |
| Arterial Wall InjuryCardiac disorders | 2/82 |
| Neurologic InjuryNervous system disorders | 2/82 |
| Non-ClassifiedCardiac disorders | 2/82 |
| ArrhythmiaCardiac disorders | 2/82 |
| InfectionInfections and infestations | 1/82 |
| Age, Continuous(years) | Treatment of Aortic Wall Injury |
|---|---|
| Median | 18 (6 to 67) |
| Age, Categorical(Participants) | Treatment of Aortic Wall Injury |
|---|---|
| <=18 years | 41 |
| Between 18 and 65 years | 38 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Treatment of Aortic Wall Injury |
|---|---|
| Female | 30 |
| Male | 52 |
| Region of Enrollment(participants) | Treatment of Aortic Wall Injury |
|---|---|
| United States | 82 |
Plan to share: No — Individual patient data is confidential and not shared.
The record gives a start of Jul 2010, a primary completion of Dec 2012 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 3 years 3 months after primary completion.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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