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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Aptus Endosystems.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Aptus Endosystems
ClinicalTrials.gov Identifier:
NCT00507559
First received: July 24, 2007
Last updated: February 14, 2012
Last verified: February 2012

July 24, 2007
February 14, 2012
September 2007
January 2014   (final data collection date for primary outcome measure)
Safety: MAE Effectiveness: Composite Success Rate [ Time Frame: Safety 30 days and Effectiveness 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00507559 on ClinicalTrials.gov Archive Site
Safety: all AEs and SAEs Effectiveness: clinical utility and device performance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
The Pivotal Study of the Aptus Endovascular AAA Repair System
The Pivotal Study of the Aptus Endovascular AAA Repair System

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysms (AAA)
Device: Aptus Endovascular AAA Repair System
EVAR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
155
March 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507559
2007-01
Yes
Aptus Endosystems
Aptus Endosystems
Not Provided
Principal Investigator: Ronald M Fairman, M.D University of Pennsylvania
Principal Investigator: Manish Mehta, M.D Albany Medical College & Albany Medical Center
Aptus Endosystems
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP