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
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Study Completion Date: April 2009
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
QUANTUM LP™ STENT GRAFT SYSTEM
Device: QUANTUM LP™ STENT GRAFT SYSTEM
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Other Name: QUANTUM LP™ STENT GRAFT SYSTEM
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: H. Wayne Hutman, MD / Director, Cordis
ClinicalTrials.gov Identifier: NCT00233688     History of Changes
Other Study ID Numbers: P01-4601
Study First Received: October 5, 2005
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014