Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft - Full Text View

Sponsor:	Lombard Medical
Information provided by:	Lombard Medical
ClinicalTrials.gov Identifier:	NCT00522535

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.In aneurysms with anatomy including angled aorta, angled aneurysmal body or both between 0° and 90°, where the patients have suitable anatomy. The aortic neck extends from the renal artery furthest from the heart to the top of the aneurysm.

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, as defined in Section 3.3.2, 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	Phase
Abdominal Aortic Aneurysms	Procedure: Open repair Procedure: EVAR	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

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:	160
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Open surgical repair of abdominal aortic aneurysm	Procedure: Open repair Open surgical repair of abdominal aortic aneurysm
2: Experimental Endovascular treatment arm of 160 patients having suitable anatomy in which the Aorfix™ is placed. 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°	Procedure: EVAR Endovascular repair of abdominal aortic aneurysm

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
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, 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
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 >85 years, or not expected to live more than 2 years from enrolment
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 39 Study Locations

Sponsors and Collaborators

Lombard Medical

Investigators

Principal Investigator:

Mark Fillinger, MD

Dartmouth-Hitchcock Medical Center

More Information

Additional Information:

Aorfix Homepage This link exits the ClinicalTrials.gov site

First US Case in a Patient with a High Angle Neck Aneurysm using Gen II Aorfix This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dartmouth-Hitchcock Medical Center ( Mark Fillinger, MD )
Study ID Numbers:	PYTHAGORAS
Study First Received:	August 27, 2007
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00522535 History of Changes
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:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on November 20, 2009