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: September 8, 2014
Last verified: September 2014

August 27, 2007
September 8, 2014
April 2006
September 2011   (final data collection date for primary outcome measure)
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 ]
The twelve month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the control group. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00522535 on ClinicalTrials.gov Archive Site
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 ]
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 control group. [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysms
  • Procedure: Open surgical repair
    Open surgical repair of abdominal aortic aneurysm
  • Device: Stent Graft
    Endovascular repair of abdominal aortic aneurysm (EVAR)
    Other Names:
    • Aorfix™ stent graft
    • Aorfix™ AAA stent graft
  • Active Comparator: Open Surgical Repair
    Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
    Intervention: Procedure: Open surgical repair
  • 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.

    Intervention: Device: 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.

    Intervention: Device: Stent Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
January 2018
September 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00522535
PYTHAGORAS
Yes
Lombard Medical
Lombard Medical
Not Provided
Principal Investigator: Mark Fillinger, MD Dartmouth-Hitchcock Medical Center
Lombard Medical
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP