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

Primary Purpose

Abdominal Aortic Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open surgical repair
Stent Graft
Sponsored by
Lombard Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring AAA, Abdominal Aortic Aneurysms, Endovascular, EVAR, Aorta, Stent Graft, Stent, Tortuous, High Angle, Angled Necks

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB Vascular Surgery
  • University of Arizona, Department of Surgery
  • Long Beach VA Healthcare System
  • UCSF Division of Vascular Surgery
  • Stanford University Medical Center
  • Harbor-UCLA Medical Center
  • Yale University School of Medicine
  • Christiana Hospital
  • Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
  • University of Florida
  • Baptist Hospital of Miami, Cardiac & Vascular Institute
  • Macon Cardiovascular Institute
  • Methodist Heart Lung & Vascular Institute
  • Springfield Memorial Hospital
  • John Hopkins Bayview Medical Center
  • Brigham and Women's Hospital
  • University of Michigan, Department of Vascular Surgery
  • Michigan Vascular Group
  • Abbott Northwestern / MHIF
  • Washington University
  • Dartmouth - Hitchcock Medical
  • Englewood Hospital & Medical Center
  • Newark-Beth Israel Medical Center
  • Albany Medical Center
  • New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery
  • Jobst Vascular Center
  • Oregon Health & Science University
  • Geisinger Medical Center
  • Pinnacle Health Hospitals
  • University of Pittsburgh
  • Moffitt Heart and Vascular Group
  • Sanford Clinic Clinical Research
  • University of Tennessee
  • DeBakey Heart Center, Methodist Hospital
  • Sentara Heart Hospital - Vascular & Transplant Specialists
  • Swedish Medical Center
  • Sacred Heart Medical Center
  • University of Wisconsin School of Medicine & Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Open Surgical Repair

Endovascular Repair

Continued Access

Arm Description

Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.

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.

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.

Outcomes

Primary Outcome Measures

Aorfix™ vs. Open Control All Cause Mortality
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.

Secondary Outcome Measures

Aorfix™ vs. Open Control Adverse Events
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.

Full Information

First Posted
August 27, 2007
Last Updated
October 25, 2021
Sponsor
Lombard Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00522535
Brief Title
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Acronym
PYTHAGORAS
Official Title
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lombard Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
AAA, Abdominal Aortic Aneurysms, Endovascular, EVAR, Aorta, Stent Graft, Stent, Tortuous, High Angle, Angled Necks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Surgical Repair
Arm Type
Active Comparator
Arm Description
Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
Arm Title
Endovascular Repair
Arm Type
Experimental
Arm Description
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.
Arm Title
Continued Access
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open surgical repair
Intervention Description
Open surgical repair of abdominal aortic aneurysm
Intervention Type
Device
Intervention Name(s)
Stent Graft
Other Intervention Name(s)
Aorfix™ stent graft, Aorfix™ AAA stent graft
Intervention Description
Endovascular repair of abdominal aortic aneurysm (EVAR)
Primary Outcome Measure Information:
Title
Aorfix™ vs. Open Control All Cause Mortality
Description
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
Secondary Outcome Measure Information:
Title
Aorfix™ vs. Open Control Adverse Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Fillinger, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Vascular Surgery
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Arizona, Department of Surgery
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Long Beach VA Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
UCSF Division of Vascular Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0128
Country
United States
Facility Name
Baptist Hospital of Miami, Cardiac & Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Macon Cardiovascular Institute
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Methodist Heart Lung & Vascular Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Springfield Memorial Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
John Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan, Department of Vascular Surgery
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Vascular Group
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Abbott Northwestern / MHIF
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth - Hitchcock Medical
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Englewood Hospital & Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Newark-Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Jobst Vascular Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Pinnacle Health Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Moffitt Heart and Vascular Group
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Sanford Clinic Clinical Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
University of Tennessee
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
DeBakey Heart Center, Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Heart Hospital - Vascular & Transplant Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin School of Medicine & Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28943010
Citation
Wang S, Hicks CW, Malas MB. Neck diameter and inner curve seal zone predict endograft-related complications in highly angulated necks after endovascular aneurysm repair using the Aorfix endograft. J Vasc Surg. 2018 Mar;67(3):760-769. doi: 10.1016/j.jvs.2017.07.114. Epub 2017 Sep 21.
Results Reference
derived
PubMed Identifier
28190716
Citation
Malas MB, Hicks CW, Jordan WD Jr, Hodgson KJ, Mills JL Sr, Makaroun MS, Belkin M, Fillinger MF; PYTHAGORAS Investigators. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. J Vasc Surg. 2017 Jun;65(6):1598-1607. doi: 10.1016/j.jvs.2016.10.120. Epub 2017 Feb 9.
Results Reference
derived
PubMed Identifier
26321596
Citation
Malas MB, Jordan WD, Cooper MA, Qazi U, Beck AW, Belkin M, Robinson W, Fillinger M. Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial. J Vasc Surg. 2015 Nov;62(5):1108-17. doi: 10.1016/j.jvs.2015.05.042. Epub 2015 Aug 28.
Results Reference
derived
Links:
URL
http://www.lombardmedical.com
Description
Lombard Medical Technologies Inc. Homepage

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Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

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