Jason T. Lee
Study of Zenith? Low Profile AAA Endovascular Graft to treat abdominla aortic aneurysm
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Primary Objective: The objective of the study is to evaluate the safety and effectiveness of the Zenith? Low Profile AAA Endovascular Graft. The primary safety endpoint will be the 30-day major adverse event rate and the primary effectiveness endpoint will be device success at 12 months. Secondary Objective: Secondary endpoints will include 30-day device success and 12-month major adverse events.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Endovascular repair of abdominal aortic aneurysm
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
A patient is deemed suitable for inclusion in the study if the patient has at least one of the following AND is suitable for treatment with the Zenith? Low Profile AAA Endovascular Graft and 16 Fr H&L-B One-Shot? Introduction System:
1) Aortic or aortoiliac aneurysm with a diameter ≥ 5.0 cm for males or ≥ 4.5 cm for females
2) Iliac aneurysm with a diameter ≥ 3.0 cm
3) Aneurysm with a history of growth ≥ 0.5 cm per year.
Key Exclusion Criteria:
General Exclusion Criteria
1) Less than 18 years of age
2) Life expectancy less than 2 years
3) Pregnant or breastfeeding or planning on becoming pregnant within 60 months
4) Unwilling to comply with the follow-up schedule
5) Inability or refusal to give informed consent
6) Less than 30 days beyond primary endpoint for other investigative drug or device study
Medical Exclusion Criteria
1) Known allergy to nitinol (nickel, titanium), polyester, polypropylene, gold, stainless steel, or solder (tin, silver)
2) History of anaphylactic reaction to contrast material that cannot be adequately premedicated
3) Leaking/ruptured or symptomatic aneurysm
4) Uncorrectable coagulopathy
5) Planned interventional or surgical procedure that is unrelated to AAA repair within 30 days before or after AAA repair
Anatomical Exclusion Criteria
1) Significant occlusive disease, tortuosity, or calcification
2) Proximal neck <15 mm in length
3) Proximal neck, measured outer wall to outer wall on a sectional image (CT)>28 mm in diameter or <18 mm in diameter
4) Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
5) Immediate suprarenal neck angulated more than 45 degrees relative to the immediate infrarenal neck
6) Proximal seal site with inverted funnel shape (change in neck diameter > 10% over the first 15 mm of proximal neck length)
7) Proximal seal site with circumferential thrombus/atheroma
8) Aortic diameter, measured outer wall to outer wall on a sectional image (CT), < 20 mm at the bifurcation
9) Iliac/femoral anatomy that is unsuitable for access with the 16 Fr (6 mm nominal sheath O.D.) introduction system
10) Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT), >20 mm or < 8 mm at distal fixation site
11) Iliac artery distal fixation site <10 mm in length
12) Indispensable inferior mesenteric artery (IMA)
13) Inability to maintain at least one patent hypogastric artery
14) Renal artery stenosis >80% (and serum creatinine >2.0 mg/dl)
15) Unsuitable arterial anatomy
Additional Study Details
Official Title:
Zenith? Low Profile AAA Endovascular Graft Clinical StudyAnticipated start date:
5/1/2008Lead Sponsor:
Cook IncorporatedInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- The objective of the study is to evaluate the safety and effectiveness of the Zenith? Low Profile AAA Endovascular Graft. The primary safety endpoint will be the 30-day major adverse event rate and the primary effectiveness endpoint will be device success at 12 months.
Secondary Outcomes:
- Secondary endpoints will include 30-day device success and 12-month major adverse events.
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
5More Information
Secondary ID(s):
- IRB: 16458, SPO: 45481
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/10/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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