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Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
This study is ongoing, but not recruiting participants.
Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00233688
  Purpose

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


Condition Intervention Phase
Abdominal Aortic Aneurysm
 Device: QUANTUM LP™ STENT GRAFT SYSTEM
Procedure: Open surgical repair
 Phase III

MedlinePlus related topics: Aneurysms
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To compare the rate and amount of blood products used in the stent graft procedure to open surgery. [ Time Frame: At procedure ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: November 2001
Estimated Study Completion Date: January 2009
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
QUANTUM LP™ STENT GRAFT SYSTEM
Device: QUANTUM LP™ STENT GRAFT SYSTEM
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
2: Active Comparator
Surgical intervention
Procedure: Open surgical repair
Open surgical repair

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233688

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

Responsible Party: Cordis ( H. Wayne Hutman, MD / Director )
Study ID Numbers: P01-4601
Study First Received: October 5, 2005
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00233688  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
 Abdominal aortic aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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