Clinical trial NCT00612924: The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
Official title: The Anaconda Endovascular Graft US FDA Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infrarenal Abdominal Aortic Aneurysm
Lead sponsor: Terumo CVS
Sponsor class: INDUSTRY
Collaborators: name: Vascutek Ltd.
First posted: 2008-02-12
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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 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.

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

Primary outcomes:
measure: Successful Aneurysm Treatment
timeFrame: 365 days
measure: Freedom From Major Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Effectiveness, Technical Success
timeFrame: 24 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Hospital
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: Los Angeles
country: United States
facility: University of Southern California Healthcare Consultation Ctr. II
state: California
city: Los Angeles
country: United States
facility: West Los Angeles VA Medical Centre
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Hospital
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Maitland
country: United States
facility: Florida Vascular Consultants
state: Florida
city: Miami
country: United States
facility: Miller School of Medicine University of Miami
state: Florida
city: Springfield
country: United States
facility: Southern Illinois Univ. School of Med.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Vascular Surgery, Methodist Hospital
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital Vascular and Endovascular Surgery
state: Massachusetts
city: Flint
country: United States
facility: Michigan Vascular Research Center
state: Michigan
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of NJ
state: New Jersey
city: Albany
country: United States
facility: Center for Vascular Awareness
state: New York
city: Buffalo
country: United States
facility: University of Buffalo surgeons, Inc.
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Norfolk
country: United States
facility: Vascular and Transplant Specialist
state: Virginia
city: Calgary
country: Canada
facility: Peter Lougheed Center
state: Alberta
city: St Johns
country: Canada
facility: St. Clare's Hospital
state: Newfoundland and Labrador
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Terumo Cardiovascular Systems Corporation
name: Steven Pregulman, MD
role: STUDY_DIRECTOR
References:
citation: Johnston SC, Wilson CB, Halbach VV, Higashida RT, Dowd CF, McDermott MW, Applebury CB, Farley TL, Gress DR. Endovascular and surgical treatment of unruptured cerebral aneurysms: comparison of risks. Ann Neurol. 2000 Jul;48(1):11-9. doi: 10.1002/1531-8249(200007)48:13.3.co;2-m.
citation: Greenberg RK, Lawrence-Brown M, Bhandari G, Hartley D, Stelter W, Umscheid T, Chuter T, Ivancev K, Green R, Hopkinson B, Semmens J, Ouriel K. An update of the Zenith endovascular graft for abdominal aortic aneurysms: initial implantation and mid-term follow-up data. J Vasc Surg. 2001 Feb;33(2 Suppl):S157-64. doi: 10.1067/mva.2001.111683.