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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00507559
First received: July 24, 2007
Last updated: October 7, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention
Abdominal Aortic Aneurysms (AAA)
Device: Aptus Endovascular AAA Repair System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pivotal Study of the Aptus Endovascular AAA Repair System

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Effectiveness: Composite Success Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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%.

  • Safety: MAE (Major Adverse Event) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Safety: SAE (Serious Adverse Event) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure

  • Effectiveness: Surgical Conversion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.


  • Effectiveness: Aneurysm Rupture [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure

  • Effectiveness: Aneurysm Change [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure

  • Effectiveness: EndoStaple Stent/Fracture [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure

  • Effectiveness: Prosthesis Migration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure

  • Effectiveness: Type I Endoleak and Type III Endoleak [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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

  • Effectiveness: Thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure


Enrollment: 155
Study Start Date: September 2007
Study Completion Date: May 2014
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AAA Repair System Device: Aptus Endovascular AAA Repair System
EVAR (endovascular aneurysm repair)

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507559

Locations
United States, New York
The Vascular Group
Albany, New York, United States, 12208
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Ronald M Fairman, M.D University of Pennsylvania
Principal Investigator: Manish Mehta, M.D Albany Medical College & Albany Medical Center
  More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00507559     History of Changes
Other Study ID Numbers: 2007-01 
Study First Received: July 24, 2007
Results First Received: April 21, 2016
Last Updated: October 7, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on December 02, 2016