The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

Launched by TERUMO CVS · Feb 11, 2008

Keywords

ClinConnect Summary

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 of symptoms or rupture. Thus aneurysm repair can be viewed as a prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured aneurysm. The decision to treat an aneurysm electively is based upon a risk to benefit ratio. Treatment options include medical management of co-morbidities (hypertension, pulmonary disease, etc.) with observation of the aneurysm, open surgi...

Gender

ALL

Eligibility criteria

• 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