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

  Show 38 Study Locations
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 April 17, 2014