Global Post-market Registry for the Treovance Stent-graft.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03449875
• Date of registration: 09/01/2018
• Prospective Registration: No
• Primary sponsor: Bolton Medical
• Public title: Global Post-market Registry for the Treovance Stent-graft. RATIONALE
• Scientific title: A Post-Market Surveillance Clinical Registry of the TREOVANCE® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
• Date of first enrolment: February 5, 2014
• Target sample size: 202
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03449875
• Study type: Observational [Patient Registry]

Countries of recruitment

Chile, Denmark, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, Thailand, United Kingdom, Venezuela, Vietnam

Contacts

• Name: Carlo Setacci, MD, PhD
• Affiliation: Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy

Key inclusion & exclusion criteria

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.)



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Abdominal Aortic Aneurysm

Intervention(s)

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

Primary Outcome(s)

Number of subjects reporting Major Adverse Events [Time Frame: Through 12 months]

Secondary Outcome(s)

Rate of Vascular Access Complications [Time Frame: 1 month, 6 months and 12 months]

Rate of Endoleaks [Time Frame: 1 month, 6 months and 12 months]

Rate of unintentional covering of renal arteries and / or hypogastric arteries [Time Frame: Procedure / Study Day 0]

Rate of Device Delivery/Deployment Success [Time Frame: Procedure / Study Day 0]

Rate of Stent-Graft Patency [Time Frame: 1 month, 6 months and 12 months]

Rate of Stent-Graft Migration greater than 10mm [Time Frame: 6 months and 12 months]

Rate of Aneurysm Sac Size Changes [Time Frame: 6 months and 12 months]

Rate of Limb Ischemia [Time Frame: 1 month, 6 months and 12 months]

Rate of Stent-Graft Integrity [Time Frame: 1 month, 6 months and 12 months]

Secondary ID(s)

IP-0024-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors