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New treatment option for Thoracoabdominal Aneurysm
Official title Repair of Thoracoabdominal Aortic Aneurysms
ClinicalTrials.gov ID: NCT03111459
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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.
See the full eligibility criteria
Who can 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.
- 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.
What rules you out
- 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.
- 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...
- 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 treatment 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: people who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.