A Clinical Study of the Safety and Performance of the Treovance Stent-Graft with Navitel Delivery System for Patients with Infrarenal Abdominal Aortic Aneurysms

Withdrawn

• Conditions: Abdominal Aortic Aneurysm (AAA); abnormal dilatation of the abdominal aorta; 10002363

• Registration Number: NL-OMON36578
• Lead Sponsor: Bolton Medical Espana S.L.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

a.) Subject must be between the ages of 18 and 85.
b.) 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.
c.) Subject must have an infrarenal AAA that
i. is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or
ii. has increased in diameter by 0.5 cm in the last 6 months
d.) 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
e.) 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
f.) Subject must have lowest renal artery at least 9 cm from the aortic bifurcation
g.) 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
h.) 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
i.) Subject must have a total treatment length of at least 13 cm
j.) Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits.
k.) 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.
l.) Subject or Legally Authorized Representative (LAR) must agree to sign Informed Consent Form

Exclusion Criteria

Subjects may not enroll into the study if any of the following apply:
a.) Subject is pregnant or lactating
b.) Subject has a dissection, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
c.) Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
d.) Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
e.) Subject has a lesion that cannot be crossed by a guide wire
f.) Proximal neck cannot increase by more than 10% over 15 mm; i.e., no trapezoidal necks
g.) 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
h.) Subject has had a stroke or MI within 6 months of the planned treatment date
i.) Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
j.) Subject has an active systemic infection or is suspected of having an active systemic infection (e.g., AIDS/HIV, sepsis)
k.) 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
l.) Subject has connective tissue disease (e.g., Marfan*s syndrome)
m.) Subject has a mycotic aneurysm
n.) Subject has significant or circumferential mural thrombus in the proximal aortic neck
o.) Subject has a blood coagulation disorder or bleeding diathesis the treatment for which cannot be suspended pre- and post-repair
p.) Subject is in acute or chronic renal failure (creatinine > 2.5 mg/dL)
q.) 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.)
r.) 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.
s.) 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.
t.) Subject has had a prior AAA repair (endovascular or surgical)
u.) Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester
v.) 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.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified