Coarctation of the AortaCOASTNCT00552812
Coarctation Of the Aorta Stent Trial
A study testing Stent therapy of aortic coarctation in people with Coarctation of the Aorta, run by Richard E. Ringel at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults. Read more about this study
- Who is it for?
- Ages 8 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coarctation of the Aorta
- What is being tested?
- Stent therapy of aortic coarctation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Native or recurrent aortic coarctation
- Weight greater than or equal to 35 kg
- Noninvasive, arm-leg cuff systolic blood pressure difference or catheter measured systolic coarctation gradient greater than or equal to 20 mmHg
Who cannot join
- Age > 60 years
- Connective tissue disorders, including Marfan syndrome and other genetic syndromes such as Turner syndrome and Noonan syndrome
- Inflammatory aortitis
- Bloodstream infection, including endocarditis
- Pregnancy
- Aortic aneurysm
Show all 9Show fewer
- Prior stent placement
- Adults lacking capacity to consent
- Foster children and/or wards of the court
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.
Read the detailed description
The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures.
The aims of the Phase One study are to assess the use of the CP bare metal stent to:
- provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient;
- accomplish gradient relief with a shorter number of days in hospital than surgery;
- accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and
- accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.
- Conditions
- Coarctation of the Aorta
- Being tested
- Stent therapy of aortic coarctation
- Keywords
- Aortic Coarctation, Heart Defects, Congenital, Stents, Heart Catheterization
- Medical subject headings
- Aortic Coarctation, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent therapy of aortic coarctationDevice
Also called Cheatham-Platinum Stent
Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
| Study group | Role | What they receive |
|---|---|---|
| Stent therapy of aortic coarctation | Experimental | Stenting of aortic coarctation Receives: Device: Stent therapy of aortic coarctation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months
Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)
Measured: 12 months
Secondary outcomes (2)
Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement
Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure > 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).
Measured: Baseline and 12 months
Systolic Blood Pressure, Difference Between Upper and Lower Extremities
Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2012
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coarctation of the AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard E. Ringel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard E. Ringel, Johns Hopkins University
- Investigators
- Richard E Ringel, MD, Principal investigator, Johns Hopkins UniversityKathy Jenkins, MD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552812
- Sponsor's protocol ID
- G060057
- Acronym
- COAST
- Status last verified
- Feb 2016
- First submitted
- 31 Oct 2007
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual patient data is confidential and is not shared.
Publications
Hu L, Sun Q, Tang L, Cai M, Qian W, Dou T, Wang H, Wu Y, Liu Y. Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects. Clin Drug Investig. 2024 Jan;44(1):79-85. doi: 10.1007/s40261-023-01334-y. Epub 2023 Dec 19.
PubMed 38112942Holzer 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.
PubMed 34039015Meadows J, Minahan M, McElhinney DB, McEnaney K, Ringel R; COAST Investigators*. Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST). Circulation. 2015 May 12;131(19):1656-64. doi: 10.1161/CIRCULATIONAHA.114.013937. Epub 2015 Apr 13.
PubMed 25869198
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coarctation Of the Aorta Stent Trial
- ClinicalTrials.gov ID
- NCT00552812
- Acronym / sponsor ID
- COAST / G060057
- Conditions
- Coarctation of the Aorta
- Keywords
- Aortic Coarctation, Heart Defects, Congenital, Stents, Heart Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Richard E. RingelUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.
Detailed description
The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures.
The aims of the Phase One study are to assess the use of the CP bare metal stent to:
- provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient;
- accomplish gradient relief with a shorter number of days in hospital than surgery;
- accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and
- accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent therapy of aortic coarctation | Experimental | Device: Stent therapy of aortic coarctationStenting of aortic coarctation |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Native or recurrent aortic coarctation
- Weight greater than or equal to 35 kg
- Noninvasive, arm-leg cuff systolic blood pressure difference or catheter measured systolic coarctation gradient greater than or equal to 20 mmHg
Key exclusion criteria (9 listed)
- Age > 60 years
- Connective tissue disorders, including Marfan syndrome and other genetic syndromes such as Turner syndrome and Noonan syndrome
- Inflammatory aortitis
- Bloodstream infection, including endocarditis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent therapy of aortic coarctationAlso: Cheatham-Platinum StentTranscatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation. | Device | Stent therapy of aortic coarctation |
Primary outcome
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months
Time frame: 12 months
Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)
2 secondary outcomes
Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement
Time frame: Baseline and 12 months
Systolic Blood Pressure, Difference Between Upper and Lower Extremities
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38112942Hu L, Sun Q, Tang L, Cai M, Qian W, Dou T, Wang H, Wu Y, Liu Y. Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects. Clin Drug Investig. 2024 Jan;44(1):79-85. doi: 10.1007/s40261-023-01334-y. Epub 2023 Dec 19.
- Derived from this study: PubMed 34039015Holzer 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.
- Derived from this study: PubMed 25869198Meadows J, Minahan M, McElhinney DB, McEnaney K, Ringel R; COAST Investigators*. Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST). Circulation. 2015 May 12;131(19):1656-64. doi: 10.1161/CIRCULATIONAHA.114.013937. Epub 2015 Apr 13.
- Individual participant dataSharing planned: No. Individual patient data is confidential and is not shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Ringel, MD principal investigator
Johns Hopkins University
Kathy Jenkins, MD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent therapy of aortic coarctation in people with Coarctation of the Aorta, run by Richard E. Ringel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552812, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.