The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

Completed · Not applicable

Conditions studied: Infrarenal Abdominal Aortic Aneurysm

In brief

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 Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System

Key facts

Study ID

NCT00612924

Run by

Terumo CVS

People needed

195

Starts

2009-04-01

Expected to finish

2017-07-13

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Arizona Heart Institute — Phoenix, Arizona, United States
• Central Arkansas Veteran's Hospital — Little Rock, Arkansas, United States
• Long Beach VA Healthcare System — Long Beach, California, United States
• University of Southern California Healthcare Consultation Ctr. II — Los Angeles, California, United States
• West Los Angeles VA Medical Centre — Los Angeles, California, United States
• Kaiser Permanente Hospital — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Florida Vascular Consultants — Maitland, Florida, United States
• Miller School of Medicine University of Miami — Miami, Florida, United States
• Southern Illinois Univ. School of Med. — Springfield, Illinois, United States
• Indiana University Vascular Surgery, Methodist Hospital — Indianapolis, Indiana, United States
• Massachusetts General Hospital Vascular and Endovascular Surgery — Boston, Massachusetts, United States
• Michigan Vascular Research Center — Flint, Michigan, United States
• University of Medicine and Dentistry of NJ — New Brunswick, New Jersey, United States
• Center for Vascular Awareness — Albany, New York, United States
• University of Buffalo surgeons, Inc. — Buffalo, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Vascular and Transplant Specialist — Norfolk, Virginia, United States
• Peter Lougheed Center — Calgary, Alberta, Canada
• St. Clare's Hospital — St. John's, Newfoundland and Labrador, Canada
• London Health Science Center — London, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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