The Pivotal Study of the Aptus Endovascular AAA Repair System

NCT00507559 | Completed Results DMC

• 1 other identifier: 2007-01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

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).

Conditions

Abdominal Aortic Aneurysms (AAA)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Safety: SAE (Serious Adverse Event)

  5 years

• Effectiveness: Surgical Conversion

  12 months

• Effectiveness: Aneurysm Rupture

  12 months

• Effectiveness: Aneurysm Change

  12 months

• Effectiveness: EndoStaple Stent/Fracture

  12 months

Study Arms (1)

AAA Repair System

EXPERIMENTAL

Device: Aptus Endovascular AAA Repair System

Interventions

Aptus Endovascular AAA Repair System DEVICE

EVAR (endovascular aneurysm repair)

AAA Repair System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (2)

The Vascular Group

Albany, New York, 12208, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Kristin Schwartz
• Organization: Medtronic Endovascular

kristin.schwartz@medtronic.com

(763) 514-4000

Study Officials

• Ronald M Fairman, M.D

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Manish Mehta, M.D

  Albany Medical College & Albany Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 26, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2014
• Last Updated: November 3, 2021
• Results First Posted: May 27, 2016

Record last verified: 2021-10

Locations

US (2)