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

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

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

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: QUANTUM LP™ STENT GRAFT SYSTEM; Procedure: Open surgical repair

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; QUANTUM LP™ STENT GRAFT SYSTEM	Device: QUANTUM LP™ STENT GRAFT SYSTEM; Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
ACTIVE_COMPARATOR: 2; Surgical intervention	Procedure: Open surgical repair; Open surgical repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Study Director: H. Wayne Hutman, MD, Cordis Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (ACTUAL): December 1, 2004
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: October 5, 2005
• First Submitted That Met QC Criteria: October 5, 2005
• First Posted (ESTIMATE): October 6, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): May 1, 2009
• Last Update Submitted That Met QC Criteria: April 30, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: P01-4601