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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lombard Medical
ClinicalTrials.gov Identifier:
NCT00522535
First received: August 27, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysms
Procedure: Open surgical repair
Device: Stent Graft

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Resource links provided by NLM:


Further study details as provided by Lombard Medical:

Primary Outcome Measures:
  • The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: April 2006
Estimated Study Completion Date: January 2018
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522535

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

Additional Information:
No publications provided

Responsible Party: Lombard Medical
ClinicalTrials.gov Identifier: NCT00522535     History of Changes
Other Study ID Numbers: PYTHAGORAS
Study First Received: August 27, 2007
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lombard Medical:
AAA
Abdominal Aortic Aneurysms
Endovascular
EVAR
Aorta
Stent Graft
Stent
Tortuous
High Angle
Angled Necks

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 24, 2014