Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft (PYTHAGORAS)
This study is ongoing, but not recruiting participants.
Sponsor:
Lombard Medical
Information provided by (Responsible Party):
Lombard Medical
ClinicalTrials.gov Identifier:
NCT00522535
First received: August 27, 2007
Last updated: April 16, 2013
Last verified: April 2013
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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 |
Resource links provided by NLM:
Further study details as provided by Lombard Medical:
Primary Outcome Measures:
- 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 ]
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 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 |
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
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Hide Study LocationsLocations
| United States, Alabama | |
| UAB Vascular Surgery | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| University of Arizona, Department of Surgery | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Long Beach VA Healthcare System | |
| Long Beach, California, United States, 90822 | |
| UCSF Division of Vascular Surgery | |
| San Francisco, California, United States, 94143 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Delaware | |
| Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610-0128 | |
| Baptist Hospital of Miami, Cardiac & Vascular Institute | |
| Miami, Florida, United States, 33176 | |
| United States, Georgia | |
| Macon Cardiovascular Institute | |
| Macon, Georgia, United States, 31201 | |
| United States, Illinois | |
| Methodist Heart Lung & Vascular Institute | |
| Peoria, Illinois, United States, 61606 | |
| Springfield Memorial Hospital | |
| Springfield, Illinois, United States, 62702 | |
| United States, Maryland | |
| John Hopkins Bayview Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan, Department of Vascular Surgery | |
| Ann Arbor, Michigan, United States, 48109 | |
| Michigan Vascular Group | |
| Flint, Michigan, United States, 48507 | |
| United States, Minnesota | |
| Abbott Northwestern / MHIF | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| Washington University | |
| St Louis, Missouri, United States, 63110 | |
| United States, New Hampshire | |
| Dartmouth - Hitchcock Medical | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Englewood Hospital & Medical Center | |
| Englewood, New Jersey, United States, 07631 | |
| Newark-Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Jobst Vascular Center | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Pinnacle Health Hospitals | |
| Harrisburg, Pennsylvania, United States, 17110 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Moffitt Heart and Vascular Group | |
| Wormleysburg, Pennsylvania, United States, 17043 | |
| United States, South Dakota | |
| Sanford Clinic Clinical Research | |
| Sioux Falls, South Dakota, United States, 57117 | |
| United States, Tennessee | |
| University of Tennessee | |
| Chattanooga, Tennessee, United States, 37403 | |
| United States, Texas | |
| DeBakey Heart Center, Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Sentara Heart Hospital - Vascular & Transplant Specialists | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
| Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| University of Wisconsin School of Medicine & Public Health | |
| Madison, Wisconsin, United States, 53792 | |
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: | 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 21, 2013