Abdominal Aortic Aneurysms (AAA)STAPLE-2NCT00507559
The Pivotal Study of the Aptus Endovascular AAA Repair System
A study testing Aptus Endovascular AAA Repair System in people with Abdominal Aortic Aneurysms (AAA), run by Medtronic Cardiovascular at 2 sites in United States.
Trial 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 (AAA). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA)
- What is being tested?
- Aptus Endovascular AAA Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to May 2014
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Vascular Group
Albany, New York, 12208
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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).
Read the detailed description
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Being tested
- Aptus Endovascular AAA Repair System
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aptus Endovascular AAA Repair SystemDevice
EVAR (endovascular aneurysm repair)
| Study group | Role | What they receive |
|---|---|---|
| AAA Repair System | Experimental | Not described Receives: Device: Aptus Endovascular AAA Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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
Measured: 30 days
Secondary outcomes (8)
Safety: SAE (Serious Adverse Event)
Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
Measured: 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.
Measured: 12 months
Effectiveness: Aneurysm Rupture
Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Measured: 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
Measured: 12 months
Effectiveness: EndoStaple Stent/Fracture
Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Measured: 12 months
Effectiveness: Prosthesis Migration
Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
Measured: 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
Measured: 12 months
Effectiveness: Thrombosis
Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2010
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal Aortic Aneurysms (AAA)Studies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald M Fairman, M.D, Principal investigator, University of PennsylvaniaManish Mehta, M.D, Principal investigator, Albany Medical College & Albany Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507559
- Sponsor's protocol ID
- 2007-01
- Acronym
- STAPLE-2
- Status last verified
- Oct 2021
- First submitted
- 24 Jul 2007
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes