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

Covidien

Status: Completed

Conditions: Abdominal Aortic Aneurysms

Treatments: Device: Endurant Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705718

Medtronic - 089

Details and patient eligibility

About

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

Full description

Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is ≥ 18 years old.
2. 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.
3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
4. 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
5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
6. Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
8. 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.
9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Endurant Bifurcated arm

Experimental group

Description:

The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm.

Treatment:

Device: Endurant Stent Graft System

Endurant AUI arm

Experimental group

Description:

The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm.

Treatment:

Device: Endurant Stent Graft System