Coarctation of the AortaNCT00978952
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
A study testing Large Diameter Advanta™ V12 Covered Stent in people with Coarctation of the Aorta, run by Atrium Medical Corporation at 9 sites in 7 countries.
Trial summary
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coarctation of the Aorta
- What is being tested?
- Large Diameter Advanta™ V12 Covered Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesin 7 countries
- Study dates
- Sep 2009to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography.
- Subject weighs a minimum of 30 kg.
- The peak pressure gradient is ≥20 mmHg systolic blood pressure across the coarctation site.
- Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon.
- Coarctation can be successfully crossed with a guide wire, sheath and device.
- Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20 mm in diameter.
- Subject is able and willing to adhere to all required follow-up visits and testing.
- Subject is able and willing to adhere to the required follow-up medication regimen.
Who cannot join
- The physician is not able to access the coarctation with standard techniques.
- Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure.
- Length of coarctation is greater than 45 mm in length.
- Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome.
- The coarctation has adjacent, acute thrombus.
- The coarctation was previously treated with a stent.
Show all 14Show fewer
- Proximity of the coarctation to an important side branch resulting in crossing of the side branch with the Large Diameter Advanta™ V12 Covered Stent device (e.g. "jailing" of the branch vessel).
- Subject has a tubular graft, interposition graft, stent graft at or near the coarctation site that would be interfere with delivery, positioning, expansion or stabilization of the Large Diameter Advanta™ V12 Covered Stent
- Subject has contrast agent hypersensitivity that cannot be adequately premedicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- Bloodstream infection
- Subject is pregnant or breastfeeding.
- Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
- The investigator deems the subject to be an inappropriate candidate for the study.
- Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now approved product are not excluded by this criterion.
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Germany3 sites
Heart Institute Berlin
Berlin
CardioVascular Center
Frankfurt, 60389
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757
Canada1 site
Hospital for Sick Children Labatt Family Heart Centre
Toronto, Ontario, M5G 1X8
United Kingdom1 site
Bristol Royal Hospital for Children and Bristol Royal Infirmary
Bristol, BS2 8BJ
About this study
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.
Read the detailed description
The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand [1]. The CCISC experience from 1989 to 2005 shows a true procedural success rate of 98.6%.
The patient population will be subjects with coarctation of the aorta. A total of 70 subjects, children, adolescents and adults, will be enrolled at up to 15 study sites. Baseline clinical and angiographic assessment will determine the subject's eligibility for enrollment in the study. Subjects will continue in the study for long term annual follow-up through 3, 4, and 5 years.
- Conditions
- Coarctation of the Aorta
- Being tested
- Large Diameter Advanta™ V12 Covered Stent
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Diameter Advanta™ V12 Covered StentDevice
Stent placement
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | Use of Large Diameter Advanta™ V12 Covered Stent. Receives: Device: Large Diameter Advanta™ V12 Covered Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy
The mean difference between Diastolic Velocity (DV)/Systolic Velocity(SV) pre and post procedure (i.e. pre procedure DV/SV - post procedure DV/SV) minus the difference between 12 month and post procedure (i.e. 12 month DV/SV - post procedure DV/SV).
Measured: 12 month
Primary Safety
30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Measured: 30 days of procedure
Secondary outcomes (3)
Secondary Safety
Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Measured: procedural (time zero)
Secondary Safety
No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.
Measured: 12 month
Secondary Safety
Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2013
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elchanan Bruckheimer, MD, Principal investigator, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978952
- Sponsor's protocol ID
- 803
- Status last verified
- Jun 2017
- First submitted
- 14 Sep 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bruckheimer E, Birk E, Benson L, Butera G, Martin R, Roberts PA, Schneider MBE, Schubert S, Sievert H, Pedra CCA. Large Diameter Advanta V12 Covered Stent Trial for Coarctation of the Aorta: COARC Study. Circ Cardiovasc Interv. 2021 Dec;14(12):e010576. doi: 10.1161/CIRCINTERVENTIONS.121.010576. Epub 2021 Nov 9.
PubMed 34749516
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
- ClinicalTrials.gov ID
- NCT00978952
- Acronym / sponsor ID
- 803
- Conditions
- Coarctation of the Aorta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Atrium Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.
Detailed description
The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand [1]. The CCISC experience from 1989 to 2005 shows a true procedural success rate of 98.6%.
The patient population will be subjects with coarctation of the aorta. A total of 70 subjects, children, adolescents and adults, will be enrolled at up to 15 study sites. Baseline clinical and angiographic assessment will determine the subject's eligibility for enrollment in the study. Subjects will continue in the study for long term annual follow-up through 3, 4, and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Device: Large Diameter Advanta™ V12 Covered StentUse of Large Diameter Advanta™ V12 Covered Stent. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography.
- Subject weighs a minimum of 30 kg.
- The peak pressure gradient is ≥20 mmHg systolic blood pressure across the coarctation site.
- Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon.
- Coarctation can be successfully crossed with a guide wire, sheath and device.
Key exclusion criteria (14 listed)
- The physician is not able to access the coarctation with standard techniques.
- Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure.
- Length of coarctation is greater than 45 mm in length.
- Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome.
- The coarctation has adjacent, acute thrombus.
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 |
|---|---|---|
| Large Diameter Advanta™ V12 Covered StentStent placement | Device | Investigational Group |
Primary outcome
Primary Efficacy
Time frame: 12 month
The mean difference between Diastolic Velocity (DV)/Systolic Velocity(SV) pre and post procedure (i.e. pre procedure DV/SV - post procedure DV/SV) minus the difference between 12 month and post procedure (i.e. 12 month DV/SV - post procedure DV/SV).
Primary Safety
Time frame: 30 days of procedure
30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
3 secondary outcomes
Secondary Safety
Time frame: procedural (time zero)
Secondary Safety
Time frame: 12 month
Secondary Safety
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 34749516Bruckheimer E, Birk E, Benson L, Butera G, Martin R, Roberts PA, Schneider MBE, Schubert S, Sievert H, Pedra CCA. Large Diameter Advanta V12 Covered Stent Trial for Coarctation of the Aorta: COARC Study. Circ Cardiovasc Interv. 2021 Dec;14(12):e010576. doi: 10.1161/CIRCINTERVENTIONS.121.010576. Epub 2021 Nov 9.
- Individual participant dataSharing planned: Undecided
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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.
Elchanan Bruckheimer, MD principal investigator
Schneider Children's Medical Center, Israel
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Diameter Advanta™ V12 Covered Stent in people with Coarctation of the Aorta, run by Atrium Medical Corporation at 9 sites in 7 countries.
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 8 inclusion and 14 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Australia, Brazil, Canada, Israel and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Efficacy (time frame: 12 month). The study lists 2 primary outcomes in all. 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 NCT00978952, which also lists 1 linked publication.
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 2 Jul 2017.