CompletedNot Applicable

Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

United States194 participantsStarted 2008-06

Plain-language summary

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject is ≥ 18 years old.
✓. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
✓. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
✓. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
✓. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
✓. Subject meets all the protocol anatomical criteria\* as demonstrated on contrast-enhanced CT or MRA
✓. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
✓. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.

✕. Subject has a life expectancy \< 1 year
✕. Subject is participating in another investigational drug or device study
✕. Subject requires emergent aneurysm treatment
✕. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
✕. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
✕. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)

Timeframe: 30 days (Safety)

Major Adverse Events Within 30 Days of Index Procedure

Timeframe: 30 days

Primary Effectiveness Endpoint (Technical Success)

Timeframe: Intra-operatively

Primary Effectiveness Endpoint (Treatment Success)

Timeframe: 12 months

NCT IDNCT00705718

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

Results submitted2014-01-31

Who can participate