Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)

Study Overview
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Brief Summary
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The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.

Official Title
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A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: QUANTUM LP™ STENT GRAFT SYSTEM
* Procedure: Open surgical repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Surgical Patients): Non-emergent surgical candidate (aneurysm has not ruptured) Patients 21 years of age or older Male or infertile Female Aneurysm >/=4.5 cm in diameter, or Aneurysm >/= twice the normal aortic diameter directly above the aneurysm, or Aneurysm >/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or Saccular aneurysm > 3.0 cm Inclusion Criteria (Stent Graft Patients) Patient meets all inclusion criteria for surgical candidate Aneurysm starts >/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable Diameter of aortic fixation zone (neck) >/= 22mm and </= 30 mm Supra renal aortic diameter </= 34 mm The required device coverage length >/= 13 cm extending from most distal main renal artery ostium to the distal anchoring site within the common iliac artery (or external iliac artery if planned occlusion of internal iliac artery) Aortic neck angulation < 60° as estimated from CT scan images or angiogram Iliac artery attachment zone diameter </= 20 mm Iliac arteries with a length of >/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system Aortic bifurcation > 18 mm in diameter Creatinine level < 2.5 mg/dl Exclusion Criteria (Surgical and Stent Graft Patients): Weight > 350 lbs. (159 Kg) Mycotic, ruptured or traumatic aneurysm Life expectancy < 2 years MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA Exclusion Criteria (Stent Graft Patients only) Aneurysm is symptomatic or tender Creatinine > 2.5 mg/dl or patient on dialysis Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>QUANTUM LP™ STENT GRAFT SYSTEM | Device: QUANTUM LP™ STENT GRAFT SYSTEM<br>* Stent Graft System for the Treatment of Abdominal Aortic Aneurysms<br>|
| Active Comparator: 2<br>Surgical intervention | Procedure: Open surgical repair<br>* Open surgical repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the aneurysm-related one-year mortality rates of the stent graft patients to open surgery patients. The purpose of having an aneurysm surgically or endovascularly repaired is to prevent death from AAA. |  | One year | 
| To compare the one-year procedure-related severe adverse event rates of the stent graft patients to open surgery patients. These events exclude aneurysm-related deaths. The endpoint for this objective will be the occurrence of any serious adverse eve |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the occurrence of severe device-related adverse events as they relate to the cause of aneurysm exclusion failures (i.e., Type I and III endoleaks, significant AAA growth, or AAA rupture). |  | 30 days, 6 mo, and annually up to five years | 
| To compare the rate and amount of blood products used in the stent graft procedure to open surgery. |  | At procedure |