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

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 24, 2007

Last Updated Date

February 14, 2012

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: MAE Effectiveness: Composite Success Rate [ Time Frame: Safety 30 days and Effectiveness 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00507559 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety: all AEs and SAEs Effectiveness: clinical utility and device performance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Pivotal Study of the Aptus Endovascular AAA Repair System

Official Title ^ICMJE

The Pivotal Study of the Aptus Endovascular AAA Repair System

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Abdominal Aortic Aneurysms (AAA)

Intervention ^ICMJE

Device: Aptus Endovascular AAA Repair System

EVAR

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

155

Estimated Completion Date

March 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00507559

Other Study ID Numbers ^ICMJE

2007-01

Has Data Monitoring Committee

Yes

Responsible Party

Aptus Endosystems

Study Sponsor ^ICMJE

Aptus Endosystems

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Ronald M Fairman, M.D	University of Pennsylvania
Principal Investigator:	Manish Mehta, M.D	Albany Medical College & Albany Medical Center

Information Provided By

Aptus Endosystems

Verification Date

February 2012

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

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