Clinical trial NCT00507559: The Pivotal Study of the Aptus Endovascular AAA Repair System
Official title: The Pivotal Study of the Aptus Endovascular AAA Repair System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysms (AAA)
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 155
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Effectiveness: Composite Success Rate
timeFrame: 12 months
measure: Safety: MAE (Major Adverse Event)
timeFrame: 30 days
Secondary outcomes:
measure: Safety: SAE (Serious Adverse Event)
timeFrame: 5 years
measure: Effectiveness: Surgical Conversion
timeFrame: 12 months
measure: Effectiveness: Aneurysm Rupture
timeFrame: 12 months
measure: Effectiveness: Aneurysm Change
timeFrame: 12 months
measure: Effectiveness: EndoStaple Stent/Fracture
timeFrame: 12 months
measure: Effectiveness: Prosthesis Migration
timeFrame: 12 months
measure: Effectiveness: Type I Endoleak and Type III Endoleak
timeFrame: 12 months
measure: Effectiveness: Thrombosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Albany
country: United States
facility: The Vascular Group
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ronald M Fairman, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany Medical College & Albany Medical Center
name: Manish Mehta, M.D
role: PRINCIPAL_INVESTIGATOR
References: