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Abdominal Aortic AneurysmsPYTHAGORASNCT00522535

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

A study testing Open surgical repair and Stent Graft in people with Abdominal Aortic Aneurysms, run by Lombard Medical at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Abdominal Aortic Aneurysms
What is being tested?
Open surgical repair and Stent Graft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
38 sitesUnited States
Study dates
Apr 2006to Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of Michigan, Department of Vascular Surgery

    Ann Arbor, Michigan, 48109

  • John Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • UAB Vascular Surgery

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Tennessee

    Chattanooga, Tennessee, 37403

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Englewood Hospital & Medical Center

    Englewood, New Jersey, 07631

  • Michigan Vascular Group

    Flint, Michigan, 48507

  • Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute

    Fort Lauderdale, Florida, 33308

  • University of Florida

    Gainesville, Florida, 32610-0128

  • Pinnacle Health Hospitals

    Harrisburg, Pennsylvania, 17110

  • DeBakey Heart Center, Methodist Hospital

    Houston, Texas, 77030

  • Dartmouth - Hitchcock Medical

    Lebanon, New Hampshire, 03756

  • Long Beach VA Healthcare System

    Long Beach, California, 90822

  • Macon Cardiovascular Institute

    Macon, Georgia, 31201

  • University of Wisconsin School of Medicine & Public Health

    Madison, Wisconsin, 53792

  • Baptist Hospital of Miami, Cardiac & Vascular Institute

    Miami, Florida, 33176

  • Abbott Northwestern / MHIF

    Minneapolis, Minnesota, 55407

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery

    New York, New York, 10032

  • Christiana Hospital

    Newark, Delaware, 19718

  • Newark-Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Sentara Heart Hospital - Vascular & Transplant Specialists

    Norfolk, Virginia, 23507

  • Methodist Heart Lung & Vascular Institute

    Peoria, Illinois, 61606

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • UCSF Division of Vascular Surgery

    San Francisco, California, 94143

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Sanford Clinic Clinical Research

    Sioux Falls, South Dakota, 57117

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Springfield Memorial Hospital

    Springfield, Illinois, 62702

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Jobst Vascular Center

    Toledo, Ohio, 43606

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

  • University of Arizona, Department of Surgery

    Tucson, Arizona, 85724

  • Moffitt Heart and Vascular Group

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

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.

Read more

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.

Being tested
Open surgical repair, Stent Graft
Keywords
AAA, Abdominal Aortic Aneurysms, Endovascular, EVAR, Aorta, Stent Graft, Stent, Tortuous, High Angle, Angled Necks
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open surgical repairProcedure or surgery

    Open surgical repair of abdominal aortic aneurysm

  • Stent GraftDevice

    Also called Aorfix™ stent graft, Aorfix™ AAA stent graft

    Endovascular repair of abdominal aortic aneurysm (EVAR)

Study groups in NCT00522535
Study groupRoleWhat they receive
Open Surgical RepairActive comparatorOpen surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
Receives: Procedure: Open surgical repair
Endovascular RepairExperimentalEndovascular 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.
Receives: Device: Stent Graft
Continued AccessExperimentalEndovascular 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.
Receives: Device: Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2007 (estimated)
  2. Study startApr 2006
  3. Primary completionSep 2011
  4. Study completionJul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522535
Sponsor's protocol ID
PYTHAGORAS
Acronym
PYTHAGORAS
Status last verified
Oct 2021
First submitted
27 Aug 2007
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28943010

  • 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.

    PubMed 28190716

  • 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.

    PubMed 26321596

Questions about this trial

What is this clinical trial studying?

A study testing Open surgical repair and Stent Graft in people with Abdominal Aortic Aneurysms, run by Lombard Medical at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aorfix™ vs. Open Control All Cause Mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00522535, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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