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

Cordis

Status and phase: Completed; Phase 3

Conditions: Abdominal Aortic Aneurysm

Treatments: Procedure: Open surgical repair; Device: QUANTUM LP™ STENT GRAFT SYSTEM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233688

P01-4601

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Surgical Patients):

1. Non-emergent surgical candidate (aneurysm has not ruptured)
2. Patients 21 years of age or older
3. Male or infertile Female
4. Aneurysm >/=4.5 cm in diameter, or
5. Aneurysm >/= twice the normal aortic diameter directly above the aneurysm, or
6. Aneurysm >/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or
7. Saccular aneurysm > 3.0 cm

Inclusion Criteria (Stent Graft Patients)

1. Patient meets all inclusion criteria for surgical candidate
2. Aneurysm starts >/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable
3. Diameter of aortic fixation zone (neck) >/= 22mm and </= 30 mm
4. Supra renal aortic diameter </= 34 mm
5. 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)
6. Aortic neck angulation < 60° as estimated from CT scan images or angiogram
7. Iliac artery attachment zone diameter </= 20 mm
8. Iliac arteries with a length of >/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites
9. Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system
10. Aortic bifurcation > 18 mm in diameter
11. Creatinine level < 2.5 mg/dl

Exclusion Criteria (Surgical and Stent Graft Patients):

1. Weight > 350 lbs. (159 Kg)
2. Mycotic, ruptured or traumatic aneurysm
3. Life expectancy < 2 years
4. MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months
5. Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA

Exclusion Criteria (Stent Graft Patients only)

1. Aneurysm is symptomatic or tender
2. Creatinine > 2.5 mg/dl or patient on dialysis
3. Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Description:

QUANTUM LP™ STENT GRAFT SYSTEM

Treatment:

Device: QUANTUM LP™ STENT GRAFT SYSTEM

2

Active Comparator group

Description:

Surgical intervention

Treatment:

Procedure: Open surgical repair