Brief Title
The Pivotal Study of the Aptus Endovascular AAA Repair System
Official Title
The Pivotal Study of the Aptus Endovascular AAA Repair System
Brief Summary
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).
Detailed Description
The historical group is the open surgical repair procedures (n=323) in the Lifeline
Foundation (now American Vascular Association Foundation).
Study Type
Interventional
Primary Outcome
Effectiveness: Composite Success Rate
Secondary Outcome
Safety: SAE (Serious Adverse Event)
Condition
Abdominal Aortic Aneurysms (AAA)
Intervention
Aptus Endovascular AAA Repair System
Study Arms / Comparison Groups
AAA Repair System
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
155
Start Date
September 2007
Completion Date
May 2014
Primary Completion Date
March 2010
Eligibility Criteria
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.
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ronald M Fairman, M.D, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00507559
Organization ID
2007-01
Responsible Party
Sponsor
Study Sponsor
Medtronic Endovascular
Study Sponsor
Ronald M Fairman, M.D, Principal Investigator, University of Pennsylvania
Verification Date
April 2016