Thoracoabdominal AneurysmNCT03111459
Repair of Thoracoabdominal Aortic Aneurysms
A study testing Medtronic Valiant Thoracoabdominal Stent Graft System in people with Thoracoabdominal Aneurysm, run by The Christ Hospital at 1 site in United States.
Trial summary
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aneurysm
- What is being tested?
- Medtronic Valiant Thoracoabdominal Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to May 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
- A patient may be entered into the study if the patient has at least one of the following:
- 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 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.
Show all 27Show fewer
- Proximal landing zone for the thoracic bifurcation stent graft that has:
- ≥ 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.
- Minimum branch vessel diameter ≥ 5 mm.
- Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm.
- Patient is ≥ 18 years of age.
- Patient has a life expectancy > 1 year.
- 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:
- Patient has a minimum branch vessel diameter less than 5 mm.
- Patients presents urgently or emergently.
- 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.
- Patient has poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).
- Patient's baseline creatinine greater than 2.0 mg/dL.
- Patient's anatomy that would not allow for maintenance of at least one hypogastric artery.
- Patient's anatomy that would not allow for primary or assisted patency of the left subclavian artery.
- Or
- Patient that meets the 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.
Who cannot join
- Patient is a good candidate for and elects open surgical repair.
- Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
- Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
- Patient is unwilling to comply with the follow-up schedule.
- Patient is unable or refuses to give informed consent.
- Urgent or emergent presentation.
Show all 28Show fewer
- Patient is pregnant or breastfeeding.
- Patient has a contained rupture.
- Patient has a ruptured aneurysm.
- Patient has a dissection in the treated portion of the aorta.
- Obstructive stenting of any or all of the visceral vessels.
- Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).
- Medical Exclusion Criteria:
- Patient has 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.
- Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
- Patient has an uncorrectable coagulopathy.
- Patient has a 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.
- Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina).
- Patient has a 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).
- Anatomical Exclusion Criteria:
- 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 Criteria:
- Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Geoffrey Answini, MD, 513-585-1777
Darlene Rock, RN,MBA, 513-585-1777, darlene.rock@thechristhospital.com
About this study
Official title: Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System 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
Patients diagnosed with TAAA have a poor medical history and require surgical intervention to extend life. Several repair techniques have been developed, but each carry risk. Open repairs are durable but have substantial perioperative mortality and postoperative morbidity. Endovascular techniques are plagued by high procedural complexity and poor branch vessel patency. Parallel techniques may have poor seal and may be prone to endoleak. In contrast, the manifold approach has circumferential seal at the proximal end of the system. It has relatively simple case planning and it has virtually no ischemic time. Due to these advantages, the Investigator believes the novel proposed technique may overcome some of the current clinical risks with other approaches.
Patients who participate in this study may benefit from having a less invasive procedure compared to open repair of their thoracoabdominal aortic aneurysm. The Investigator expects the amount of discomfort, total blood loss, recovery time, and overall hospital stay to be less than open repair. Many of the patients presenting with a thoracoabdominal aneurysm are not candidates for open repair due to existing comorbidities. With the progressive nature of the disease, these patients have limited options for medical intervention and are willing to assume a higher amount of risk.
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. For a Type I or II thoracoabdominal aneurysm the proximal seal is in zone 3, for Type III and V the device seals in zone 4. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold. The smaller 16 mm limb of the thoracic bifurcation extends to the infrarenal segment to either seal in zone 9 for a Type I and V and in zone 10 for Type II and III. All other connections in the device make use of sizes that are modular and independent of patient anatomy.
The Medtronic Valiant Thoracoabdominal Stent Graft works to bifurcate aortic flow upstream of the target visceral vessels. This bifurcation has a two-fold benefit. First it allows for aortic flow to be compartmentalized into a visceral segment and an infrarenal segment providing for uninterrupted flow to the visceral vessels as well as the infrarenal segment throughout the procedure. If any of the connections cannot be made or the patient status declines during the procedure, then it can be staged and the connections can be made at a later date. Second, the upstream bifurcation encourages more favorable flow conditions in the bridging stents and target vessels which may prevent target vessel occlusion. This is due to the fact that the bifurcations are upstream providing a sweeping transition into the renal arteries that is smooth providing for relatively laminar flow conditions. The design demonstrates that more central aortic flow is obtained with this design increasing flow rates in the visceral vessels to potentially increase target vessel patency.
The device can be used as an off-the-shelf system, negating the need for lead times associated with custom-built devices. The critical sizing will need to be done with the proximal end of the thoracic bifurcation, distal landing zone in the aorta or iliac arteries, and the bridging stents. The proximal end of the thoracic bifurcation can be sized by choosing any of the available sizes of the Medtronic TAAA thoracic bifurcation stent grafts, and the sizes of the bridging stents can be manipulated by choosing any of the commercially available sizes of the Atrium iCast. The Atrium iCasts are added to the system in-vivo and connected with passive fixation which negates the need to size the main body components based on the target vessel sizes. All other connections in the device make use of sizes that are the same, independent of patient anatomy.
The deployment of this device is also independent of device alignment. Angular alignment of the thoracic bifurcation and the visceral manifold has very little impact on the outcome of the case. Longitudinal alignment is more important, but a safety factor has been built-in by calling for the distal ends of the visceral manifold to be deployed above their target vessels by 1-2 cm. The longitudinal landing should be optimized so that the graft is not landed too low that the connection with the visceral vessels is challenging to make.
Patients included in the study will undergo follow-up at one month, six months, twelve months and then annually for five years.
- Conditions
- Thoracoabdominal Aneurysm
- Being tested
- Medtronic Valiant Thoracoabdominal Stent Graft System
- Keywords
- endograft repair,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Valiant Thoracoabdominal Stent Graft SystemDevice
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
| Study group | Role | What they receive |
|---|---|---|
| Primary Study Arm | Experimental | Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System. Receives: Device: Medtronic Valiant Thoracoabdominal Stent Graft System |
| Expanded Selection Arm | Experimental | Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System. Receives: Device: Medtronic Valiant Thoracoabdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects free from major adverse events
major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Measured: 30 days
Secondary outcomes (1)
Treatment Success at follow-up intervals
Treatment success includes freedom from: 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 and 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 posted12 Apr 2017
- Study start1 Aug 2017
- Primary completionMay 2024 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal AneurysmStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Geoffrey Answini, The Christ Hospital
- Investigators
- Geoffrey Answini, MD, Principal investigator, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111459
- Sponsor's protocol ID
- ISR-2016-10790
- Status last verified
- Feb 2024
- First submitted
- 28 Mar 2017
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)
- ClinicalTrials.gov ID
- NCT03111459
- Acronym / sponsor ID
- ISR-2016-10790
- Conditions
- Thoracoabdominal Aneurysm
- Keywords
- endograft repair,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 12 Apr 2017 (actual)
- 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 clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System 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
Patients diagnosed with TAAA have a poor medical history and require surgical intervention to extend life. Several repair techniques have been developed, but each carry risk. Open repairs are durable but have substantial perioperative mortality and postoperative morbidity. Endovascular techniques are plagued by high procedural complexity and poor branch vessel patency. Parallel techniques may have poor seal and may be prone to endoleak. In contrast, the manifold approach has circumferential seal at the proximal end of the system. It has relatively simple case planning and it has virtually no ischemic time. Due to these advantages, the Investigator believes the novel proposed technique may overcome some of the current clinical risks with other approaches.
Patients who participate in this study may benefit from having a less invasive procedure compared to open repair of their thoracoabdominal aortic aneurysm. The Investigator expects the amount of discomfort, total blood loss, recovery time, and overall hospital stay to be less than open repair. Many of the patients presenting with a thoracoabdominal aneurysm are not candidates for open repair due to existing comorbidities. With the progressive nature of the disease, these patients have limited options for medical intervention and are willing to assume a higher amount of risk.
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. For a Type I or II thoracoabdominal aneurysm the proximal seal is in zone 3, for Type III and V the device seals in zone 4. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold. The smaller 16 mm limb of the thoracic bifurcation extends to the infrarenal segment to either seal in zone 9 for a Type I and V and in zone 10 for Type II and III. All other connections in the device make use of sizes that are modular and independent of patient anatomy.
The Medtronic Valiant Thoracoabdominal Stent Graft works to bifurcate aortic flow upstream of the target visceral vessels. This bifurcation has a two-fold benefit. First it allows for aortic flow to be compartmentalized into a visceral segment and an infrarenal segment providing for uninterrupted flow to the visceral vessels as well as the infrarenal segment throughout the procedure. If any of the connections cannot be made or the patient status declines during the procedure, then it can be staged and the connections can be made at a later date. Second, the upstream bifurcation encourages more favorable flow conditions in the bridging stents and target vessels which may prevent target vessel occlusion. This is due to the fact that the bifurcations are upstream providing a sweeping transition into the renal arteries that is smooth providing for relatively laminar flow conditions. The design demonstrates that more central aortic flow is obtained with this design increasing flow rates in the visceral vessels to potentially increase target vessel patency.
The device can be used as an off-the-shelf system, negating the need for lead times associated with custom-built devices. The critical sizing will need to be done with the proximal end of the thoracic bifurcation, distal landing zone in the aorta or iliac arteries, and the bridging stents. The proximal end of the thoracic bifurcation can be sized by choosing any of the available sizes of the Medtronic TAAA thoracic bifurcation stent grafts, and the sizes of the bridging stents can be manipulated by choosing any of the commercially available sizes of the Atrium iCast. The Atrium iCasts are added to the system in-vivo and connected with passive fixation which negates the need to size the main body components based on the target vessel sizes. All other connections in the device make use of sizes that are the same, independent of patient anatomy.
The deployment of this device is also independent of device alignment. Angular alignment of the thoracic bifurcation and the visceral manifold has very little impact on the outcome of the case. Longitudinal alignment is more important, but a safety factor has been built-in by calling for the distal ends of the visceral manifold to be deployed above their target vessels by 1-2 cm. The longitudinal landing should be optimized so that the graft is not landed too low that the connection with the visceral vessels is challenging to make.
Patients included in the study will undergo follow-up at one month, six months, twelve months and then annually for five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Study Arm | Experimental | Device: Medtronic Valiant Thoracoabdominal Stent Graft SystemPatients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System. |
| Expanded Selection Arm | Experimental | Device: Medtronic Valiant Thoracoabdominal Stent Graft SystemPatients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- A patient may be entered into the study if the patient has at least one of the following:
- 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 that has:
- Minimum branch vessel diameter ≥ 5 mm.
- Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm.
Key exclusion criteria (28 listed)
- Patient is a good candidate for and elects open surgical repair.
- Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
- Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
- Patient is unwilling to comply with the follow-up schedule.
- Patient is unable or refuses 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 |
|---|---|---|
| Medtronic Valiant Thoracoabdominal Stent Graft SystemThe Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold. | Device | Expanded Selection Arm, Primary Study Arm |
Primary outcome
Proportion of subjects free from major adverse events
Time frame: 30 days
major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
1 secondary outcome
Treatment Success at follow-up intervals
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 8 Feb 2024.
- 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.
Geoffrey Answini, MD principal investigator
The Christ Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Valiant Thoracoabdominal Stent Graft System in people with Thoracoabdominal Aneurysm, run by The Christ Hospital 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 27 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 8 Feb 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?
Contact Geoffrey Answini, MD (513-585-1777, geoffrey.answini@thechristhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects free from major adverse events (time frame: 30 days). 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 Feb 2024.