The Pivotal Study of the Aptus Endovascular AAA Repair System

Abdominal Aortic Aneurysms (AAA) Clinical Trial

— STAPLE-2  

Official title:

The Pivotal Study of the Aptus Endovascular AAA Repair System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507559
• Other study ID #: 2007-01
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: May 2014

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: May 2014
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms (AAA)
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Aptus Endovascular AAA Repair System
EVAR (endovascular aneurysm repair)

Locations

Country	Name	City	State
United States	The Vascular Group	Albany	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	12 months
Primary	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	30 days
Secondary	Safety: SAE (Serious Adverse Event)	Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure	5 years
Secondary	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.	12 months
Secondary	Effectiveness: Aneurysm Rupture	Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure	12 months
Secondary	Effectiveness: Aneurysm Change	Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure	12 months
Secondary	Effectiveness: EndoStaple Stent/Fracture	Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure	12 months
Secondary	Effectiveness: Prosthesis Migration	Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure	12 months
Secondary	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	12 months
Secondary	Effectiveness: Thrombosis	Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure	5 years