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

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ClinicalTrials.gov Identifier: NCT00233688
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : May 1, 2009
Information provided by:
Cordis Corporation

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

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: QUANTUM LP™ STENT GRAFT SYSTEM Procedure: Open surgical repair Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON
Study Start Date : November 2001
Primary Completion Date : December 2004
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Active Comparator: 2
Surgical intervention
Procedure: Open surgical repair
Open surgical repair

Primary Outcome Measures :
  1. 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. [ Time Frame: One year ]
  2. 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 [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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). [ Time Frame: 30 days, 6 mo, and annually up to five years ]
  2. To compare the rate and amount of blood products used in the stent graft procedure to open surgery. [ Time Frame: At procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233688

United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Sponsors and Collaborators
Cordis Corporation
Study Director: H. Wayne Hutman, MD Cordis Corporation

Responsible Party: H. Wayne Hutman, MD / Director, Cordis
ClinicalTrials.gov Identifier: NCT00233688     History of Changes
Other Study ID Numbers: P01-4601
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases