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PYTHAGORAS

Summary of Trial: 
 
The purpose of this study is to evaluate the safety and effectiveness of the Aorfix stent graft in the treatment of infrarenal abdominal aortic aneurysm repair. Specifically, the study will determine the device safety by the primary endpoint of freedom from serious adverse events up to one year, and the device efficacy by the primary endpoint of survival at one year.
Principal Investigator:Mahmoud B Malas, M.D., MHS, FACS
Study Coordinator:

Umair Qazi, M.D., MPH
Email: uqazi1@jhmi.edu

Study Long Title: 

Prospective aneurysm trial: High angle Aorfix bifurcated stent graft

Study Short Title: PYTHAGORAS
JHU IRB Number:

NA_00010411411

Funding Source:Lombard Medical Inc
Important Inclusion Criteria:Patients for both study arms must meet the following criteria to be enrolled in this study.

The inclusion criteria are:

  1. Diagnosed abdominal aortic aneurysm with aortic neck angles up to 90°, > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolisation), 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
  2. Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.
Important Exclusion Criteria:

Exclusion criteria
Patients for either arm of the study will be excluded if any of the following is true.

General

  1. Less than 21 years of age,
  2. Life expectancy less than 2 years,
  3. Pregnant,
  4. Religious, cultural or other objection to the receipt of blood, or blood products,
  5. Unwillingness to comply with follow-up schedule,
  6. Unwillingness or inability to provide informed consent to both trial and procedure.

Medical

  1. Patients not expected to live more than 2 years from enrolment..
  2. Patient has a ruptured aneurysm.
  3. Aneurysm extends above renal arteries.
  4. Aorta between superior mesenteric artery (SMA) and aneurysm has significant loose thrombus associated with it.
  5. Patient with an acute or chronic aortic dissection or mycotic aneurysm.
  6. Patient has current non-localized infection (may be recruited following remission of the infection).
  7. Patient is allergic to device materials,
  8. 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.
  9. Patient is clinically and morbidly obese such that imaging would be severely adversely affected.
  10. Patient has renal failure (serum creatinine > 2.5mg/dL).
  11. Patient has an uncorrectable bleeding abnormality.
  12. Patient has unstable angina.
  13. Patient is receiving dialysis.
  14. Inflammatory aneurysm.
  15. MI in last 6 months.
  16. End stage COPD.
  17. Patient has connective tissue disease (e.g. Marfan syndrome, Ehlers-Danlos syndrome).
  18. Significant (>80%) renal artery stenosis which cannot be readily treated.

Endovascular arm exclusion criteria

  1. Patient has co-morbidities that deny vascular access, or small access vessels.
  2. Patient has highly calcified and/or tortuous proximal neck or distal landing zones or iliac arteries.
  3. Patient has insufficient length of proximal aneurysm neck (< 15mm from lowest renal artery) or SMA to aneurysm distance is less than 20mm,
  4. Patient has insufficient length of distal landing zone (< 15mm).
  5. Proximal neck is outside of device range (reference sizing tables, 0).
  6. The iliac artery diameter (landing zone) is larger than 19 mm in diameter (reference sizing tables, section 0).
  7. Indispensable Inferior Mesenteric Artery (IMA),
  8. Inability to maintain at least one patent hypogastric artery,
  9. Excessive calcification, such as a ring, or near ring of calcified plaque around an iliac artery.

Prospective participants excluded from the endovascular study arms may be eligible for inclusion in the open arm.
Excessive tortuosity, calcification and thrombus are at the discretion of the principle investigator at each site.
Participants will be assigned aortic and/or aneurysmal angles based by the investigating center and this will be confirmed by an assessment of the pre-interventional data by the core laboratory. This evaluation will be conducted by the core laboratory and will occur prior to enrolment according to SVS accepted measurement criteria.

Open arm exclusion criteria

  1. Excessive calcification or occlusive disease which would prevent open repair in the opinion of the principle site investigator,
  2. Any portion of the aneurysm is supra-renal,
  3. Aneurysm involves visceral arteries,
  4. Otherwise eligible for the endovascular arm.
Clinical Trial Site: Johns Hopkins Bayview Medical Center
4940 Eastern Ave
Baltimore MD 21224
Start Date:2007
Anticipated End Date:2014
Compensation for Participating: None











































 

 

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