The Pivotal Study of the Aptus Endovascular AAA Repair System

NCT ID: NCT00507559

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-05-31

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).

Conditions

Abdominal Aortic Aneurysms (AAA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AAA Repair System

Group Type: EXPERIMENTAL

Aptus Endovascular AAA Repair System

Intervention Type: DEVICE

EVAR (endovascular aneurysm repair)

Interventions

Aptus Endovascular AAA Repair System

EVAR (endovascular aneurysm repair)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald M Fairman, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Manish Mehta, M.D

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College & Albany Medical Center

Locations

The Vascular Group

Albany, New York, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2007-01

Identifier Type: -

Identifier Source: org_study_id