The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

Terumo

Status

Completed

Conditions

Infrarenal Abdominal Aortic Aneurysm

Treatments

Device: Anaconda Stent Graft System

Device: Anaconda ONE-LOK Stent Graft System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00612924

G030036 (Other Identifier)

ANA-006

Details and patient eligibility

About

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

Full 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 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 surgical aneurysm repair through a transabdominal or retroperitoneal approach, and endovascular aneurysm repair. The decision to intervene is based upon physician judgment. Once the decision to intervene is made, the mode of the intervention must be chosen. Although open surgical repair is more invasive and has been noted to have a higher morbidity and mortality(1;2) than most endovascular reports, few argue with the effectiveness of the procedure. To date, open surgical repair remains the gold standard of care for the aneurysm patient. Endovascular repair has several beneficial characteristics in comparison to an open surgical approach. They include the potential for decreased need for blood transfusions, shorter intensive care unit and total hospital stays, the lack of endotracheal intubation, to name a few. However, the procedure requires adequate imaging prior to graft placement and during the follow-up period, in addition to the availability of a trained team to ensure proper device placement.

Enrollment

195 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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