Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft (PYTHAGORAS)
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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 hypotheses:
Efficacy:
The twelve month, all cause mortality rate in the Aorfix™ group will be non-inferior to the twelve month, all cause mortality rate in the 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 control group.
| Condition | Intervention |
|---|---|
|
Abdominal Aortic Aneurysms |
Procedure: Open 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 |
- 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 ] [ 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 210 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | September 2016 |
| 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 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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Show 38 Study Locations| 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: | April 16, 2013 |
| 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 May 19, 2013