Active — Not RecruitingNot Applicable

Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

United States158 participantsStarted 2013-11-23

Plain-language summary

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Who can participate

Age range18 Years – 85 Years

SexALL

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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 4 months of planned implant procedure
✓. 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
✓. 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 outside 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 outside diameter of 16 mm-30 mm
✓. Subject's infrarenal landing neck must 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 8 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 meet the vessel size requirements specified for the corresponding devices in the IFU

Exclusion criteria

✕. Subject is pregnant or lactating
✕. Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic 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 10% over 15mm or more than 7% over 10mm; i.e., no trapezoidal 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 Congestive Heart Failure (CHF)
✕. Subject has had a stroke or myocardial infarction within 6 months of the planned treatment date

What they're measuring

Primary Efficacy

Timeframe: 12 months

Primary Safety

Timeframe: 30 days

Trial details

NCT IDNCT02009644

SponsorBolton Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03-20

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm (AAA) trials