Thoracoabdominal Aortic AneurysmNCT03113383
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
A study testing Thoracoabdominal Aortic Aneurysm Repair in people with Thoracoabdominal Aortic Aneurysm, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Thoracoabdominal Aortic Aneurysm Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2017to 6 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient is a good candidate for and elects for open surgical repair
- Can be treated in accordance with the instructions for use with a legally marketed endovascular device
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent
- Urgent or emergent presentation
Show all 46Show fewer
- Patient is pregnant or breastfeeding
- Patient has a contained rupture
- Patient has a ruptured aneurysm
- Patient has a dissection in the portion of the aorta intended to be treated
- Obstructive stenting of any or all of the visceral vessels
- Poor performance status including two major system failures (including but not limited to cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
- Medical Exclusion Criteria
- Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium) polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
- Uncorrectable coagulopathy
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
- Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned less than 30 days of the endovascular repair
- Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- Systemic or local infection that may increase the risk of endovascular graft infection
- Baseline creatinine greater than or equal to 2.0 mg/dL
- History of connective tissue disorders (e.g., Marfan Syndrome in the primary arm only, not applicable for patients in the the expanded access arm, Ehler's Danlos Syndrome)
- Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
- Anatomical exclusion criteria:
- Minimum branch vessel diameter less than 5 mm
- Thrombus or excessive calcification in the proximal aortic neck
- Anatomy that would not allow maintenance of at least one patent hypogastric artery
- Anatomy that would not allow primary or assisted patency of the left subclavian artery
- Expanded Selection Arm Inclusion Criteria
- Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:
- Minimum branch vessel diameters <less than 5mm
- Urgent or emergent presentation
- Patient has a contained rupture
- Patient has a ruptured aneurysm
- Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated
- Poor performance status including two major system failures (including but not limited to cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
- Baseline creatinine greater than greater than or equal to 2.0 mg/dL
- Anatomy that does not allow for maintenance of at least one hypogastric artery
- Anatomy that does not allow primary or assisted patency of the left subclavian artery
- Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
- Obstructive stenting of any or all of the visceral vessels
- Or
- A patient that meets the criteria for inclusion into the primary study arm and:
- Would not be eligible for the primary study arm per a documented reason other than those outlined above, and
- Per the opinion of the Principal Investigator, with concurrence of the IRB, alternatives therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
- These will be determined by standard of care assessments of their disease/aneurysm morphology by the treating investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).
Read the detailed description
The primary purpose of this study is to evaluate the safety of this device as there are no or very limited devices and clinical options available for this patient population. The primary safety endpoint of this study is safety freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. The primary safety endpoint will be analyzed to determine statistical significance when compared to a target performance goal. A literature review of outcomes of open surgical repair was used to create the performance goal as there is not a comparable endovascular option to use for analysis. The performance goal was selected based on the range of subjects experiencing a major adverse event at 30 days. The range was calculated based on assumptions of the minimum and maximum number of subjects experiencing at least one MAE in the historical open surgical repair group . Based on the literature reviewed and the above assumptions the range of subjects experiencing at least one MAE in the open surgical repair group is 30.5% to 77.4%.
The primary effectiveness endpoint is the proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes with the number of study subjects with treatment success compared to the overall patient population.
Additionally, data outcomes from this study will be entered into a common vascular database so that data can be pooled with other PS-IDEs. This would provide consistent reporting across the PS-IDEs. Additionally, the PS-IDEs will be evaluating the same device and endpoints to allow for a pool-ability of data across the sites.
The pooled data will be separated into two separate study arms: primary study arm and expanded selection arm.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- Thoracoabdominal Aortic Aneurysm Repair
- Keywords
- Thoracoabdominal Aortic Aneurysm, Endovascular Aneurysm Repair, Stent-Graft
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoabdominal Aortic Aneurysm RepairDevice
Thoracoabdominal aortic aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| Primary Arm | Experimental | Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. Receives: Device: Thoracoabdominal Aortic Aneurysm Repair |
| Expanded Selection Arm | Experimental | Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. Receives: Device: Thoracoabdominal Aortic Aneurysm Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 30 days.
Measured: 30 days
Preliminary Effectiveness
Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year.
Measured: 1 year
Secondary outcomes (12)
Secondary Safety Endpoint:Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 6 Months.
Measured: 6 months
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 1 year.
Measured: 1 year.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 2 years.
Measured: 2 years.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 3 years.
Measured: 3 years.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 4 years.
Measured: 4 years.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 5 years.
Measured: 5 years.
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 30 days as defined by aneurysm exclusion.
Measured: 30 days.
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 6 months as defined by aneurysm exclusion.
Measured: 6 months.
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 2 years as defined by aneurysm exclusion.
Measured: 2 years.
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 3 years as defined by aneurysm exclusion.
Measured: 3 years.
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 4 years as define by aneurysm exclusion.
Measured: 4 years.
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 5 years as define by aneurysm exclusion.
Measured: 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start18 Aug 2017
- Primary completion2 Mar 2018
- Study completion6 Oct 2021
Why it stopped: Device recalled by the manufacturer
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.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Thomas Naslund, Vanderbilt University Medical Center
- Investigators
- Thomas C Naslund, MD, Principal investigator, Chief, Division of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113383
- Sponsor's protocol ID
- 161627
- Status last verified
- Oct 2022
- First submitted
- 10 Apr 2017
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data outcomes from this study will be entered into a common vascular database so that data can be pooled with other PS-IDEs. This would provide consistent reporting across the PS-IDEs. Additionally, the PS-IDEs will be evaluating the same device and endpoints to allow for a pool-ability of data across the sites. The pooled data will be separated into two separate study arms: primary study arm and expanded selection arm.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03113383
- Acronym / sponsor ID
- 161627
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Keywords
- Thoracoabdominal Aortic Aneurysm, Endovascular Aneurysm Repair, Stent-Graft
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device recalled by the manufacturer
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 10 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).
Detailed description
The primary purpose of this study is to evaluate the safety of this device as there are no or very limited devices and clinical options available for this patient population. The primary safety endpoint of this study is safety freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. The primary safety endpoint will be analyzed to determine statistical significance when compared to a target performance goal. A literature review of outcomes of open surgical repair was used to create the performance goal as there is not a comparable endovascular option to use for analysis. The performance goal was selected based on the range of subjects experiencing a major adverse event at 30 days. The range was calculated based on assumptions of the minimum and maximum number of subjects experiencing at least one MAE in the historical open surgical repair group . Based on the literature reviewed and the above assumptions the range of subjects experiencing at least one MAE in the open surgical repair group is 30.5% to 77.4%.
The primary effectiveness endpoint is the proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes with the number of study subjects with treatment success compared to the overall patient population.
Additionally, data outcomes from this study will be entered into a common vascular database so that data can be pooled with other PS-IDEs. This would provide consistent reporting across the PS-IDEs. Additionally, the PS-IDEs will be evaluating the same device and endpoints to allow for a pool-ability of data across the sites.
The pooled data will be separated into two separate study arms: primary study arm and expanded selection arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Arm | Experimental | Device: Thoracoabdominal Aortic Aneurysm RepairUse of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. |
| Expanded Selection Arm | Experimental | Device: Thoracoabdominal Aortic Aneurysm RepairUse of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (46 listed)
- Patient is a good candidate for and elects for open surgical repair
- Can be treated in accordance with the instructions for use with a legally marketed endovascular device
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent
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 |
|---|---|---|
| Thoracoabdominal Aortic Aneurysm RepairThoracoabdominal aortic aneurysm repair | Device | Expanded Selection Arm, Primary Arm |
Primary outcome
Safety Endpoint: Freedom From Major Adverse Events
Time frame: 30 days
Freedom from major adverse events (MAE) at 30 days.
Preliminary Effectiveness
Time frame: 1 year
Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year.
12 secondary outcomes
Secondary Safety Endpoint:Freedom From Major Adverse Events
Time frame: 6 months
Secondary Safety Endpoint: Freedom From Major Adverse Events
Time frame: 1 year.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Time frame: 2 years.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Time frame: 3 years.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Time frame: 4 years.
Secondary Safety Endpoint: Freedom From Major Adverse Events
Time frame: 5 years.
Secondary Effectiveness Assessment
Time frame: 30 days.
Secondary Effectiveness Assessment
Time frame: 6 months.
Secondary Effectiveness Assessment
Time frame: 2 years.
Secondary Effectiveness Assessment
Time frame: 3 years.
Secondary Effectiveness Assessment
Time frame: 4 years.
Secondary Effectiveness Assessment
Time frame: 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data outcomes from this study will be entered into a common vascular database so that data can be pooled with other PS-IDEs. This would provide consistent reporting across the PS-IDEs. Additionally, the PS-IDEs will be evaluating the same device and endpoints to allow for a pool-ability of data across the sites. The pooled data will be separated into two separate study arms: primary study arm and expanded selection arm.
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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.
Thomas C Naslund, MD principal investigator
Chief, Division of Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoabdominal Aortic Aneurysm Repair in people with Thoracoabdominal Aortic Aneurysm, run by Vanderbilt University Medical Center 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 0 inclusion and 46 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: stopped early, as of the sponsor's last update on 8 Nov 2022. 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 10 Feb 2022). 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?
Safety Endpoint: Freedom From Major Adverse Events (time frame: 30 days). 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?
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 8 Nov 2022.