PYTHAGORAS: Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Sponsor

Lombard Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT00522535

Collaborator

(none)

230

Enrollment

Locations

Arms

171

Duration (Months)

6.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysms	Procedure: Open surgical repair Device: Stent Graft	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Aorfix™ vs. Open Control All Cause Mortality [1 year]
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.

Secondary Outcome Measures

Aorfix™ vs. Open Control Adverse Events [30 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UAB Vascular Surgery	Birmingham	Alabama	United States	35294
2	University of Arizona, Department of Surgery	Tucson	Arizona	United States	85724
3	Long Beach VA Healthcare System	Long Beach	California	United States	90822
4	UCSF Division of Vascular Surgery	San Francisco	California	United States	94143
5	Stanford University Medical Center	Stanford	California	United States	94305
6	Harbor-UCLA Medical Center	Torrance	California	United States	90502
7	Yale University School of Medicine	New Haven	Connecticut	United States	06510
8	Christiana Hospital	Newark	Delaware	United States	19718
9	Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute	Fort Lauderdale	Florida	United States	33308
10	University of Florida	Gainesville	Florida	United States	32610-0128
11	Baptist Hospital of Miami, Cardiac & Vascular Institute	Miami	Florida	United States	33176
12	Macon Cardiovascular Institute	Macon	Georgia	United States	31201
13	Methodist Heart Lung & Vascular Institute	Peoria	Illinois	United States	61606
14	Springfield Memorial Hospital	Springfield	Illinois	United States	62702
15	John Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
16	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
17	University of Michigan, Department of Vascular Surgery	Ann Arbor	Michigan	United States	48109
18	Michigan Vascular Group	Flint	Michigan	United States	48507
19	Abbott Northwestern / MHIF	Minneapolis	Minnesota	United States	55407
20	Washington University	Saint Louis	Missouri	United States	63110
21	Dartmouth - Hitchcock Medical	Lebanon	New Hampshire	United States	03756
22	Englewood Hospital & Medical Center	Englewood	New Jersey	United States	07631
23	Newark-Beth Israel Medical Center	Newark	New Jersey	United States	07112
24	Albany Medical Center	Albany	New York	United States	12208
25	New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery	New York	New York	United States	10032
26	Jobst Vascular Center	Toledo	Ohio	United States	43606
27	Oregon Health & Science University	Portland	Oregon	United States	97239
28	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
29	Pinnacle Health Hospitals	Harrisburg	Pennsylvania	United States	17110
30	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15232
31	Moffitt Heart and Vascular Group	Wormleysburg	Pennsylvania	United States	17043
32	Sanford Clinic Clinical Research	Sioux Falls	South Dakota	United States	57117
33	University of Tennessee	Chattanooga	Tennessee	United States	37403
34	DeBakey Heart Center, Methodist Hospital	Houston	Texas	United States	77030
35	Sentara Heart Hospital - Vascular & Transplant Specialists	Norfolk	Virginia	United States	23507
36	Swedish Medical Center	Seattle	Washington	United States	98122
37	Sacred Heart Medical Center	Spokane	Washington	United States	99204
38	University of Wisconsin School of Medicine & Public Health	Madison	Wisconsin	United States	53792