Thoracoabdominal AneurysmsNCT02294435
Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms
A study testing Visceral Manifold and Thoracic Bifurcation and Unitary Manifold in people with Thoracoabdominal Aneurysms, run by Sanford Health at 1 site in United States.
Trial summary
The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aneurysms
- What is being tested?
- Visceral Manifold and Thoracic Bifurcation and Unitary Manifold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- An aneurysm with a maximum diameter of ≥ 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- Aneurysm with a history of growth ≥ 0.5 cm in 6 months
- Saccular aneurysm deemed at significant risk for rupture
- Symptomatic aneurysm greater than or equal to 4.5 cm
- Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
- Proximal landing zone for the thoracic bifurcation stent graft:
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- •≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA)
- Diameter in the range of 26-42 mm
- Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
- Proximal landing zone for the unitary manifold stent graft:
- Nonaneurysmal aortic segment including previously placed graft material (neck) with a minimum seal zone length of 3 cm
- Diameter in the range of 19-32 mm
- Iliac artery or aortic distal fixation site greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
- Age: ≥ 18 years old
- Life expectancy: > 1 year
Who cannot join
- General exclusion
- 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
- 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
Show all 46Show fewer
- Urgent or emergent presentation
- 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 (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)
- 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 < 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 2.0 mg/dL
- History of connective tissue disorders (e.g., Marfan Syndrome, 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 within the neck of the aneurysm
- 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 diameter less than 5 mm
- 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 (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
- Baseline creatinine greater than or equal to 2.0 mg/dL
- Anatomy that would not allow for maintenance of at least one hypogastric artery
- Anatomy that would not allow for 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 the 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
- Patient that meets criteria for inclusion in 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, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Read the detailed description
The primary objective of the clinical investigation Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary 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). Additionally, the study will assess technical success and treatment success at each follow-up interval.
- Conditions
- Thoracoabdominal Aneurysms
- Being tested
- Visceral Manifold and Thoracic Bifurcation, Unitary Manifold
- Keywords
- Thoracoabdominal Aneurysms, Endovascular, Ps-ide, Early Feasibility, Aneurysm, Aortic Aneurysm, Thoracic, Aortic Aneurysm, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases, Pararenal aneurysm, Juxtarenal aneurysm, Aortic dissection, Short neck infrarenal aneurysm, Type 4 thoracoabdominal, TAAA
- Medical subject headings
- Aneurysm, Aortic Aneurysm, Thoracic, Aortic Aneurysm, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral Manifold and Thoracic BifurcationDevice
Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system
Unitary ManifoldDevice
Unitary Manifold Endovascular stent graft system
| Study group | Role | What they receive |
|---|---|---|
| Primary Study Arm | Experimental | The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcation and the Visceral Manifold and the Unitary Manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. Receives: Device: Visceral Manifold and Thoracic Bifurcation; Device: Unitary Manifold |
| Expanded Selection Arm | Experimental | The expanded selection arm is for subjects not eligible for open repair or other endovascular options due to comorbidities or anatomical limitations and do not meet inclusion in the primary study arm. The Thoracic Bifurcation and the Visceral Manifold as well as the Unitary Manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. Receives: Device: Visceral Manifold and Thoracic Bifurcation; Device: Unitary Manifold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse events (MAEs) at 30 days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Measured: 30 days
Secondary outcomes (2)
Treatment success and technical success at 1 year
Treatment success is defined as a composite of technical success and freedom from the following:
- Aneurysm enlargement
- Aneurysm rupture
- Aneurysm-related mortality
- Conversion to open repair
- Secondary intervention for migration, Type I and III endoleaks, device integrity failure , and patency-related events
Measured: 1 year
Treatment success at various timepoints
Treatment success and the individual components of treatment success including freedom from the following:
- Aneurysm enlargement
- Aneurysm-related mortality
- Aneurysm rupture
- Conversion to open repair
- Secondary intervention for migration, type I and III endoleaks, device integrity failure, and patency-related events.
- Renal failure
- All-cause mortality
- Endoleaks
- Device integrity failure
- Patency-related events
- Other device-related events
Measured: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion31 Jan 2024
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal AneurysmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- Dakota Vascular
- Responsible party
- Principal investigator, Patrick Kelly, Dakota Vascular
- Investigators
- Patrick Kelly, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294435
- Sponsor's protocol ID
- SH VMS
- Status last verified
- Dec 2024
- First submitted
- 14 Nov 2014
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
PubMed 24997805Jorgensen BD, Malek M, VandenHull A, Remund T, Truong KC, Pohlson K, Kelly PW. A novel physician-assembled endograft for the repair of pararenal, paravisceral, Crawford type IV thoracoabdominal aortic aneurysms, and aneurysms requiring treatment after prior repair. J Vasc Surg. 2020 Dec;72(6):1897-1905.e2. doi: 10.1016/j.jvs.2020.03.045. Epub 2020 Apr 23.
PubMed 32335306
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02294435
- Acronym / sponsor ID
- SH VMS
- Conditions
- Thoracoabdominal Aneurysms
- Keywords
- Thoracoabdominal Aneurysms, Endovascular, Ps-ide, Early Feasibility, Aneurysm, Aortic Aneurysm, Thoracic, Aortic Aneurysm, Aortic Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- Dakota Vascular
- Study start
- Feb 2015 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Nov 2014 (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.
The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Detailed description
The primary objective of the clinical investigation Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary 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). Additionally, the study will assess technical success and treatment success at each follow-up interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Study Arm | Experimental | Device: Visceral Manifold and Thoracic Bifurcation, Device: Unitary ManifoldThe TAAA Debranching Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcation and the Visceral Manifold and the Unitary Manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. |
| Expanded Selection Arm | Experimental | Device: Visceral Manifold and Thoracic Bifurcation, Device: Unitary ManifoldThe expanded selection arm is for subjects not eligible for open repair or other endovascular options due to comorbidities or anatomical limitations and do not meet inclusion in the primary study arm. The Thoracic Bifurcation and the Visceral Manifold as well as the Unitary Manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- An aneurysm with a maximum diameter of ≥ 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- Aneurysm with a history of growth ≥ 0.5 cm in 6 months
- Saccular aneurysm deemed at significant risk for rupture
- Symptomatic aneurysm greater than or equal to 4.5 cm
- Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
Key exclusion criteria (46 listed)
- General exclusion
- 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
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Unwilling to comply with the follow-up schedule
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 |
|---|---|---|
| Visceral Manifold and Thoracic BifurcationVisceral Manifold and Thoracic Bifurcation Endovascular stent graft system | Device | Expanded Selection Arm, Primary Study Arm |
| Unitary ManifoldUnitary Manifold Endovascular stent graft system | Device | Expanded Selection Arm, Primary Study Arm |
Primary outcome
Freedom from major adverse events (MAEs) at 30 days
Time frame: 30 days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
2 secondary outcomes
Treatment success and technical success at 1 year
Time frame: 1 year
Treatment success at various timepoints
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 24997805Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
- Derived from this study: PubMed 32335306Jorgensen BD, Malek M, VandenHull A, Remund T, Truong KC, Pohlson K, Kelly PW. A novel physician-assembled endograft for the repair of pararenal, paravisceral, Crawford type IV thoracoabdominal aortic aneurysms, and aneurysms requiring treatment after prior repair. J Vasc Surg. 2020 Dec;72(6):1897-1905.e2. doi: 10.1016/j.jvs.2020.03.045. Epub 2020 Apr 23.
- Individual participant dataSharing planned: No
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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.
Patrick Kelly, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral Manifold and Thoracic Bifurcation and Unitary Manifold in people with Thoracoabdominal Aneurysms, run by Sanford Health 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 15 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Freedom from major adverse events (MAEs) at 30 days (time frame: 30 days). 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 NCT02294435, which also lists 2 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 16 Dec 2024.