The Pivotal Study of the Aptus Endovascular AAA Repair System (STAPLE-2)

Covidien

Status

Completed

Conditions

Abdominal Aortic Aneurysms (AAA)

Treatments

Device: Aptus Endovascular AAA Repair System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00507559

2007-01

Details and patient eligibility

About

A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).

Full description

The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).

Enrollment

155 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infrarenal AAA with a maximum diameter ≥ 4.5 cm.
Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck.
Infrarenal AAA with a proximal neck internal diameter between 19-29 mm.
Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm.
Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm.
Bilateral iliac artery distal fixation sites ≥ 10 mm in length.
Bilateral iliac arteries with an internal diameter between 9 and 20 mm.
Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.

Exclusion criteria

Myocardial infarction within past 10 weeks.
Active systemic infection.
Ruptured or leaking AAA.
Mycotic or inflammatory AAA.
Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes).
Concomitant TAA or thoracoabdominal aortic aneurysms.
Requires emergent AAA surgery.
Previous AAA repair.
Patients with a body habitus that would prevent imaging required by the study.
Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery.
Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair.
Dialysis dependent renal failure or creatinine > 2.5 mg/dL.
Allergy to or intolerance of radiopaque contrast agents.
Patients with a known sensitivity or allergy to implant materials.
Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure.
Patients with history of bleeding diathesis or hypercoagulable condition.
Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone.
Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.