The Pivotal Study of the Aptus Endovascular AAA Repair System (STAPLE-2)
This study is ongoing, but not recruiting participants.
Sponsor:
Aptus Endosystems
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
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Aortic Aneurysms (AAA) |
Device: Aptus Endovascular AAA Repair System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 Aptus Endosystems:
Primary Outcome Measures:
- Safety: MAE Effectiveness: Composite Success Rate [ Time Frame: Safety 30 days and Effectiveness 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety: all AEs and SAEs Effectiveness: clinical utility and device performance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 155 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Aptus Endovascular AAA Repair System
EVAR
Eligibility| Ages Eligible for Study: | 21 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507559
Locations
| United States, California | |
| Aptus Endosystems, Inc. | |
| Sunnyvale, California, United States, 94085 | |
Sponsors and Collaborators
Aptus Endosystems
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
Additional Information:
No publications provided
| Responsible Party: | Aptus Endosystems |
| ClinicalTrials.gov Identifier: | NCT00507559 History of Changes |
| Other Study ID Numbers: | 2007-01 |
| Study First Received: | July 24, 2007 |
| Last Updated: | February 14, 2012 |
| 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 May 16, 2013