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

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).

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysms (AAA)
• Intervention / Treatment: Device: Aptus Endovascular AAA Repair System

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
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • The Vascular Group
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AAA Repair System	Device: Aptus Endovascular AAA Repair System; EVAR (endovascular aneurysm repair)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Composite Success Rate	Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.	12 months
Safety: MAE (Major Adverse Event)	Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: SAE (Serious Adverse Event)	Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure	5 years
Effectiveness: Surgical Conversion	Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device.	12 months
Effectiveness: Aneurysm Rupture	Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure	12 months
Effectiveness: Aneurysm Change	Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure	12 months
Effectiveness: EndoStaple Stent/Fracture	Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure	12 months
Effectiveness: Prosthesis Migration	Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure	12 months
Effectiveness: Type I Endoleak and Type III Endoleak	Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure	12 months
Effectiveness: Thrombosis	Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure	5 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Ronald M Fairman, M.D, University of Pennsylvania; Principal Investigator: Manish Mehta, M.D, Albany Medical College & Albany Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 24, 2007
• First Submitted That Met QC Criteria: July 25, 2007
• First Posted (Estimate): July 26, 2007

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2007-01