Back to resultsThe Pivotal Study of the Aptus Endovascular AAA Repair System (STAPLE-2)
Primary Purpose
Abdominal Aortic Aneurysms (AAA)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aptus Endovascular AAA Repair System
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysms (AAA)
Eligibility 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.
Sites / Locations
- The Vascular Group
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AAA Repair System
Arm Description
Outcomes
Primary Outcome Measures
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%.
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
Secondary Outcome Measures
Safety: SAE (Serious Adverse Event)
Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
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.
Effectiveness: Aneurysm Rupture
Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Effectiveness: Aneurysm Change
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
Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Effectiveness: Prosthesis Migration
Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
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
Effectiveness: Thrombosis
Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Full Information
NCT ID
NCT00507559
First Posted
July 24, 2007
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
1. Study Identification
Unique Protocol Identification Number
NCT00507559
Brief Title
The Pivotal Study of the Aptus Endovascular AAA Repair System
Acronym
STAPLE-2
Official Title
The Pivotal Study of the Aptus Endovascular AAA Repair System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 (AAA).
Detailed Description
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms (AAA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAA Repair System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Aptus Endovascular AAA Repair System
Intervention Description
EVAR (endovascular aneurysm repair)
Primary Outcome Measure Information:
Title
Effectiveness: Composite Success Rate
Description
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%.
Time Frame
12 months
Title
Safety: MAE (Major Adverse Event)
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Safety: SAE (Serious Adverse Event)
Description
Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
Time Frame
5 years
Title
Effectiveness: Surgical Conversion
Description
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.
Time Frame
12 months
Title
Effectiveness: Aneurysm Rupture
Description
Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Time Frame
12 months
Title
Effectiveness: Aneurysm Change
Description
Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure
Time Frame
12 months
Title
Effectiveness: EndoStaple Stent/Fracture
Description
Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Time Frame
12 months
Title
Effectiveness: Prosthesis Migration
Description
Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
Time Frame
12 months
Title
Effectiveness: Type I Endoleak and Type III Endoleak
Description
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
Time Frame
12 months
Title
Effectiveness: Thrombosis
Description
Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Fairman, M.D
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manish Mehta, M.D
Organizational Affiliation
Albany Medical College & Albany Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Vascular Group
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Pivotal Study of the Aptus Endovascular AAA Repair System
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