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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233688
First received: October 5, 2005
Last updated: April 30, 2009
Last verified: April 2009
History of Changes

October 5, 2005
April 30, 2009
November 2001
December 2004   (final data collection date for primary outcome measure)
  • 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 ]
  • · 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.
  • · 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
Complete list of historical versions of study NCT00233688 on ClinicalTrials.gov Archive Site
  • 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 ]
  • · 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).
  • · To compare the rate and amount of blood products used in the stent graft procedure to open surgery.
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
  • Device: QUANTUM LP™ STENT GRAFT SYSTEM
    Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
    Other Name: QUANTUM LP™ STENT GRAFT SYSTEM
  • Procedure: Open surgical repair
    Open surgical repair
  • Experimental: 1
    QUANTUM LP™ STENT GRAFT SYSTEM
    Intervention: Device: QUANTUM LP™ STENT GRAFT SYSTEM
  • Active Comparator: 2
    Surgical intervention
    Intervention: Procedure: Open surgical repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2009
December 2004   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00233688
P01-4601
Yes
H. Wayne Hutman, MD / Director, Cordis
Cordis Corporation
Not Provided
Study Director: H. Wayne Hutman, MD Cordis Corporation
Cordis Corporation
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP