Aortic Aneurysm
Conditions
Brief summary
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
Interventions
DEVICEPhysician-Modified Terumo Treo Abdominal Stent-Graft System
A physician modified Terumo Treo abdominal stent-graft system will be used during repair surgery for type II, III and IV thoracoabdominal aortic aneurysms.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An aneurysm with a maximum diameter of \>5.5cm in males and \>5.0cm in females in 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 * Extent of aorta to be treated: type II, III and IV thoracoabdominal. * Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of \<1 liter or uncorrectable coronary disease, frailty, hostile abdomen. * Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit. * Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a: * Minimum neck length of 15mm * Diameter in the range of 17-32 * Minimum branch vessel diameter greater than 5 mm * Iliac artery distal fixation site * An inside diameter of 8mm - 13mm and a length of ≥ 10mm or * an inside diameter of \> 13mm - 20mm and a length of ≥ 15mm * Age: ≥50 years old
Exclusion criteria
* Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis * 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 by subject or legal representative * Subject is pregnant or breastfeeding * Ruptured aneurysms * Prior aortic repair * Patient is eligible for treatment with an FDA-approved marketed device and patient can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution. * Known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, PTFE, stainless steel, platinum/iridium, tantalum markers. * 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 exceed the safe capacity of the equipment * Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of 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 * Thrombus or excessive calcification within the neck of the aneurysm * Branch stenosis \>50% not amenable to endovascular preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of study subjects with treatment success at 1 year | 1 year | Treatment success is defined as freedom from the following: * Aneurysm enlargement: \>5mm as compared to any previous CT measure using orthogonal (i.e., perpendicular to the centerline) measurements. * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events) * Graft infection * Disabling Stroke * Permanent dialysis Results are reported as a percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of procedures that achieve technical success | 1 year | Technical success is defined as: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits * Successful delivery and Deployment at the intended implantation site * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels. * Successful withdrawal of the delivery system * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of Type I and III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging (CTA, MRA or duplex ultrasound) Results are reported as a percentage |
Countries
United States
Contacts
CONTACTPia Geisselmaier
PRINCIPAL_INVESTIGATORYoung Erben, MD
Mayo Clinic
Outcome results
None listed