Status:
COMPLETED
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
Lead Sponsor:
Terumo CVS
Collaborating Sponsors:
Vascutek Ltd.
Conditions:
Infrarenal Abdominal Aortic Aneurysm
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda S...
Detailed Description
Abdominal aortic aneurysms afflict a large number of patients in the United States and world-wide. The treatment of this disorder is based upon the concept of aneurysm repair prior to the presentation...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female ≥18 and ≤ 85 years of age. Females must be non-pregnant, non-lactating, and not planning to become pregnant during the study period
- Females of childbearing potential must use acceptable methods of contraception, be at least one year post-menopausal or be surgically sterile
- Willing and able to comply with the 5 year follow-up period
- Willing to give informed written consent prior to enrollment
- Males with infrarenal AAA ≥ 4.5cm in diameter, or AAA growth ≥ 1.0cm/yr; females with infrarenal AAA ≥ 4.0cm in diameter, or AAA growth ≥ 1.0cm/yr
- Infrarenal AAA with a proximal neck diameter of 16.0 - 31.0mm (Anaconda Stent Graft System)
- Infrarenal AAA with a proximal neck diameter of 17.5 - 31.0mm (Anaconda ONE-LOK Stent Graft System)
- Infrarenal AAA with at least 15mm length of non-aneurysm proximal neck
- Infrarenal AAA with an angle of ≤ 60 degrees relative to the long axis of the aneurysm
- Iliac artery distal fixation sites ≥ 20mm in length
- Iliac artery distal fixation site ≤ 21mm in diameter
- Ability to preserve at least one hypogastric artery
- Femoral/iliac artery access vessels, size and morphology should be compatible with the appropriate introducer sheath (18 F, 20 F or 23 F).
- Exclusion Criteria;
- Pregnant and lactating females or females of childbearing potential unless using acceptable method contraception
- Known sensitivity or allergy to nitinol or polyester
- Known allergy or intolerance of radiopaque contrast agents which cannot be pre-treated
- Thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180 degrees) continuous coverage of the vessel circumference in the intended fixation site
- Irregularly shaped calcification and/or plaque that may compromise the sealing and fixation at the proximal or distal fixation sites
- Ruptured or leaking AAA
- Mycotic or inflammatory AAA
- Genetic connective tissue disorder (i.e. Marfans or Ehlers-Danlos syndromes)
- Previous AAA repair
- Requires emergent AAA repair
- Concomitant thoracoabdominal aortic aneurysm
- Active systemic infection
- Myocardial infarction ≤10 weeks prior to procedure
- Aneurysm extends above renal arteries
- Dialysis dependent renal failure or creatinine \> 2.5mg/dL
- Significant (\>80%) renal artery stenosis not readily treatable
- End-stage chronic obstructive pulmonary disorder
- Patient is clinically and morbidly obese such that the required imaging would be prevented
- Patient has an uncorrectable bleeding abnormality
- Subject has other medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- treatment
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00612924
Start Date
April 1 2009
End Date
July 13 2017
Last Update
October 16 2017
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
2
Central Arkansas Veteran's Hospital
Little Rock, Arkansas, United States, 72205
3
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
4
University of Southern California Healthcare Consultation Ctr. II
Los Angeles, California, United States, 90033-4612