Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft (PYTHAGORAS)

October 25, 2021 updated by: Lombard Medical

Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.

Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.

Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.

Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Vascular Surgery
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona, Department of Surgery
    • California
      • Long Beach, California, United States, 90822
        • Long Beach VA healthcare System
      • San Francisco, California, United States, 94143
        • UCSF Division of Vascular Surgery
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
      • Gainesville, Florida, United States, 32610-0128
        • University of Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami, Cardiac & Vascular Institute
    • Georgia
      • Macon, Georgia, United States, 31201
        • Macon Cardiovascular Institute
    • Illinois
      • Peoria, Illinois, United States, 61606
        • Methodist Heart Lung & Vascular Institute
      • Springfield, Illinois, United States, 62702
        • Springfield Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • John Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, Department of Vascular Surgery
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Group
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern / MHIF
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth - Hitchcock Medical
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital & Medical Center
      • Newark, New Jersey, United States, 07112
        • Newark-Beth Israel Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Jobst Vascular Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health Hospitals
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh
      • Wormleysburg, Pennsylvania, United States, 17043
        • Moffitt Heart and Vascular Group
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Clinic Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University of Tennessee
    • Texas
      • Houston, Texas, United States, 77030
        • DeBakey Heart Center, Methodist Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Heart Hospital - Vascular & Transplant Specialists
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Spokane, Washington, United States, 99204
        • Sacred Heart Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin School of Medicine & Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or
  • Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.

Exclusion Criteria:

  • Less than 21 years of age,
  • Life expectancy less than 2 years,
  • Pregnant,
  • Religious cultural or other objection to the receipt of blood or blood products,
  • Unwilling to comply with follow-up schedule,
  • Unwillingness or inability to provide informed consent to both trial and procedure.
  • Patients not expected to live more than 2 years from enrollment
  • Patient has a ruptured aneurysm
  • Aneurysm extends above renal arteries
  • Proximal neck of aneurysm has significant loose thrombus associated with it
  • Patient with an acute or chronic aortic dissection or mycotic aneurysm
  • Patient has current non-localized infection (may be recruited following remission of the infection)
  • Patient is allergic to device materials
  • Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl
  • Patient is clinically and morbidly obese such that imaging would be severely adversely affected
  • Patient has renal failure (serum creatinine > 2.5 mg/dL)
  • Patient has an uncorrectable bleeding abnormality
  • Patient has unstable angina
  • Patient is receiving dialysis:
  • Inflammatory aneurysm
  • MI in last 6 months
  • End stage COPD
  • Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)
  • Significant (>80%) renal artery stenosis which cannot be readily treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Open Surgical Repair
Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
Procedure: Open surgical repair
Open surgical repair of abdominal aortic aneurysm
EXPERIMENTAL: Endovascular Repair

Endovascular treatment arm of 160 patients having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. Use of stent grafts in aortic angles greater than 60° has not been approved for other devices available in the US. As a result, a minimum of 120 patients in this arm will have an aortic angle between 60° and 90°.

Patient recruitment completed; 5-year follow-up evaluations continue.
Device: Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Other Names:
  • Aorfix™ stent graft
  • Aorfix™ AAA stent graft
EXPERIMENTAL: Continued Access

Endovascular treatment arm of 50 patients maximum having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. This Arm will provide active sites with ongoing device access while FDA reviews the PMA.

Patient recruitment completed; 5-year patient follow-ups continue.
Device: Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Other Names:
  • Aorfix™ stent graft
  • Aorfix™ AAA stent graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aorfix™ vs. Open Control All Cause Mortality
Time Frame: 1 year
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aorfix™ vs. Open Control Adverse Events
Time Frame: 30 days
The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lombard Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (ESTIMATE)

August 29, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PYTHAGORAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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