Global Post-market Registry for the Treovance Stent-graft. (RATIONALE)

Bolton Medical

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: TREOVANCE® Stent-Graft with Navitel® Delivery System

Study type: Observational

Funder types: Industry

Identifiers

NCT03449875

IP-0024-17

Details and patient eligibility

About

Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.

Full description

The goal of the registry was to collect clinical data of TREOVANCE® device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology is treated with an acceptable technical success rate, an acceptable complication rate and that the device performs as expected.

The following endovascular measures/parameters were assessed for preliminary performance at the follow-up intervals: delivery/deployment, stent-graft migration, stent-graft patency, stent-graft integrity, endoleak, aneurysm sac size changes, limb ischemia, and vascular access complications.

This registry was a prospective, multi-center, post-market non-randomized study. The goal was to gather safety and performance data on the device. Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE® Stent-Graft with Navitel® Delivery System. Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1, 6, and 12 months post-implantation.

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be between the ages of 18 and 85.
• Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 3 months of planned implant procedure.
• Subject must have an infrarenal AAA that i. is > 4.5 cm in diameter for females and > 5 cm for males. ii. has increased in diameter by 0.5 cm in the last 6 months
• Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 17 mm - 32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 16 mm-30 mm
• Subject's infrarenal landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
• Subject must have lowest renal artery at least 9 cm from the aortic bifurcation
• Subject must have a distal iliac landing neck with i. an inside diameter of 7 mm - 13 mm and a length of at least 10 mm, or ii. an inside diameter of >13 mm - 20 mm and a length of at least 15 mm
• Subject's distal iliac landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified for the corresponding devices in the IFU
• Subject must have a total treatment length of at least 13 cm
• Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits.
• Subject must have adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the Navitel® Delivery System which is 18F (6 mm) or 19F (6.3 mm) outer diameter based on size of device used. Alternatively, subject's anatomy is suitable for creation of an iliac conduit.
• Subject or Legally Authorized Representative (LAR) must agree to sign hospital issued Informed Consent Form

Exclusion criteria

• Subject is pregnant or lactating
• Subject has a dissection or a ruptured aneurysm (as determined by treating physician).
• Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
• Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
• Subject has a lesion that cannot be crossed by a guide wire
• Proximal neck cannot increase by more than 20% over 15 mm; i.e., no conical necks
• Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction < 20%, or recent diagnosis of CHF
• Subject has had a stroke or MI within 6 months of the planned treatment date
• Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
• Subject has an active systemic infection or is suspected of having an active systemic infection (e.g., AIDS/HIV, sepsis)
• Subject is morbidly obese (more than 100% over the ideal body weight or as defined by institutional standards) or has other clinical conditions that severely compromise or impair x-ray visualization of the aorta
• Subject has significant or circumferential mural thrombus in the proximal aortic neck
• Subject has a blood coagulation disorder or bleeding diathesis the treatment for which cannot be suspended pre- and post-repair
• Subject is in acute or chronic renal failure (creatinine > 2.5 mg/dL)
• Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.)
• Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure.
• Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion.
• Subject has had a prior AAA repair (endovascular or surgical)
• Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester
• Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., CABG, organ transplantation, renal stenting, etc.)