The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

Study Overview
=================
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.

Official Title
-----------------
The Anaconda Endovascular Graft US FDA Phase II Clinical Study

Conditions
-----------------
Infrarenal Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Anaconda Stent Graft System
* Device: Anaconda ONE-LOK Stent Graft System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anaconda<br> | Device: Anaconda Stent Graft System<br>* Endovascular device<br>Device: Anaconda ONE-LOK Stent Graft System<br>* Endovascular device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Aneurysm Treatment | defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of: Aneurysm growth ≥ 5 mm as evaluated by the core laboratory Post-operative interventions to correct type I or III endoleaks Conversion to open surgical repair Failed patency of both limbs Migration requiring secondary procedure or intervention Significant fracture Aneurysm rupture | 365 days | 
| Freedom From Major Adverse Events | The reported values represent the patients that did not experience a Major Adverse Event. Participants did NOT experience: All-Cause Mortality Myocardial Infarction (MI) Cerebrovascular Accident (CVA) Renal Failure Respiratory Failure Paralysis or Paraplegia, or Bowel Ischemia | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Effectiveness, Technical Success | Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations. | 24 hours |