Repairing thoracoabdominal aortic aneurysms using a new stent graft system

Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)

This study is testing a new stent graft system to see if it can safely and effectively repair thoracoabdominal aortic aneurysms with less risk than traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Christ Hospital (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT03111459 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the Medtronic Valiant Thoracoabdominal Stent Graft System for repairing thoracoabdominal aortic aneurysms (TAAA) in patients with suitable anatomy. The study aims to assess the safety and preliminary effectiveness of this endovascular approach, which is designed to be less invasive than traditional open repair methods. By utilizing a novel manifold technique, the study seeks to minimize complications associated with existing repair techniques, such as high perioperative mortality and postoperative morbidity. Follow-up assessments will measure technical and treatment success over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with thoracoabdominal aortic aneurysms that meet specific anatomical criteria and have a maximum diameter greater than 5.5 cm or a history of significant growth.

Not a fit: Patients who may not benefit from this study include those with aneurysms that do not meet the anatomical requirements or those who are not suitable candidates for any surgical intervention.

Why it matters

Potential benefit: If successful, this approach could provide patients with a less invasive option for repairing thoracoabdominal aortic aneurysms, leading to reduced discomfort and shorter recovery times.

How similar studies have performed: Other studies have shown promise with similar endovascular approaches, suggesting potential for success with this novel technique.

Eligibility criteria

Inclusion Criteria:

1. A patient may be entered into the study if the patient has at least one of the following:

   1. 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
   2. aneurysm with a history of growth \> 0.5 cm in 6 months
   3. saccular aneurysm deemed at significant risk for rupture
   4. symptomatic aneurysm greater than 4.5 cm
2. 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.
3. Proximal landing zone for the thoracic bifurcation stent graft that has:

   1. ≥ 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.
   2. 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.
4. Minimum branch vessel diameter ≥ 5 mm.
5. 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.
6. Patient is ≥ 18 years of age.
7. Patient has a life expectancy \> 1 year.

Exclusion Criteria:

1. Patient is a good candidate for and elects open surgical repair.
2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
4. Patient is unwilling to comply with the follow-up schedule.
5. Patient is unable or refuses to give informed consent.
6. Urgent or emergent presentation.
7. Patient is pregnant or breastfeeding.
8. Patient has a contained rupture.
9. Patient has a ruptured aneurysm.
10. Patient has a dissection in the treated portion of the aorta.
11. Obstructive stenting of any or all of the visceral vessels.
12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).

Medical Exclusion Criteria:

1. 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.
2. Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
3. Patient has an uncorrectable coagulopathy.
4. Patient has a body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
5. Patient has had a major surgical or interventional procedure. unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair.
6. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina).
7. Patient has a systemic or local infection that may increase the risk of endovascular graft infection.
8. Baseline creatinine greater than 2.0 mg/dL.
9. History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome).

Anatomical Exclusion Criteria:

1. Thrombus or excessive calcification within the neck of the aneurysm.
2. Anatomy that would not allow maintenance of at least one patent hypogastric artery.
3. 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.

Inclusion Criteria:

1. 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:

   1. Patient has a minimum branch vessel diameter less than 5 mm.
   2. Patients presents urgently or emergently.
   3. Patient has a contained rupture.
   4. Patient has a ruptured aneurysm.
   5. Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated.
   6. Patient has poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).
   7. Patient's baseline creatinine greater than 2.0 mg/dL.
   8. Patient's anatomy that would not allow for maintenance of at least one hypogastric artery.
   9. Patient's anatomy that would not allow for primary or assisted patency of the left subclavian artery.

   Or
2. Patient that meets the criteria for inclusion in the primary study arm and:

   1. Would not be eligible for the primary study arm per a documented reason other than those outlined above, and
   2. 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.

Where this trial is running

Cincinnati, Ohio

• The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Geoffrey Answini, MD — The Christ Hospital
• Study coordinator: Geoffrey Answini, MD

Conditions Thoracoabdominal Aneurysm; endograft repair,