search
Back to results

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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
QUANTUM LP™ STENT GRAFT SYSTEM
Open surgical repair
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Surgical Patients): Non-emergent surgical candidate (aneurysm has not ruptured) Patients 21 years of age or older Male or infertile Female Aneurysm >/=4.5 cm in diameter, or Aneurysm >/= twice the normal aortic diameter directly above the aneurysm, or Aneurysm >/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or Saccular aneurysm > 3.0 cm Inclusion Criteria (Stent Graft Patients) Patient meets all inclusion criteria for surgical candidate Aneurysm starts >/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable Diameter of aortic fixation zone (neck) >/= 22mm and </= 30 mm Supra renal aortic diameter </= 34 mm 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) Aortic neck angulation < 60° as estimated from CT scan images or angiogram Iliac artery attachment zone diameter </= 20 mm Iliac arteries with a length of >/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system Aortic bifurcation > 18 mm in diameter Creatinine level < 2.5 mg/dl Exclusion Criteria (Surgical and Stent Graft Patients): Weight > 350 lbs. (159 Kg) Mycotic, ruptured or traumatic aneurysm Life expectancy < 2 years MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA Exclusion Criteria (Stent Graft Patients only) Aneurysm is symptomatic or tender Creatinine > 2.5 mg/dl or patient on dialysis Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface

Sites / Locations

  • Newark Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

QUANTUM LP™ STENT GRAFT SYSTEM

Surgical intervention

Outcomes

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.
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

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).
To compare the rate and amount of blood products used in the stent graft procedure to open surgery.

Full Information

First Posted
October 5, 2005
Last Updated
April 30, 2009
Sponsor
Cordis Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00233688
Brief Title
Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
QUANTUM LP™ STENT GRAFT SYSTEM
Arm Title
2
Arm Type
Active Comparator
Arm Description
Surgical intervention
Intervention Type
Device
Intervention Name(s)
QUANTUM LP™ STENT GRAFT SYSTEM
Intervention Description
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Intervention Type
Procedure
Intervention Name(s)
Open surgical repair
Intervention Description
Open surgical repair
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
To compare the rate and amount of blood products used in the stent graft procedure to open surgery.
Time Frame
At procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Surgical Patients): Non-emergent surgical candidate (aneurysm has not ruptured) Patients 21 years of age or older Male or infertile Female Aneurysm >/=4.5 cm in diameter, or Aneurysm >/= twice the normal aortic diameter directly above the aneurysm, or Aneurysm >/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or Saccular aneurysm > 3.0 cm Inclusion Criteria (Stent Graft Patients) Patient meets all inclusion criteria for surgical candidate Aneurysm starts >/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable Diameter of aortic fixation zone (neck) >/= 22mm and </= 30 mm Supra renal aortic diameter </= 34 mm 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) Aortic neck angulation < 60° as estimated from CT scan images or angiogram Iliac artery attachment zone diameter </= 20 mm Iliac arteries with a length of >/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system Aortic bifurcation > 18 mm in diameter Creatinine level < 2.5 mg/dl Exclusion Criteria (Surgical and Stent Graft Patients): Weight > 350 lbs. (159 Kg) Mycotic, ruptured or traumatic aneurysm Life expectancy < 2 years MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA Exclusion Criteria (Stent Graft Patients only) Aneurysm is symptomatic or tender Creatinine > 2.5 mg/dl or patient on dialysis Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Wayne Hutman, MD
Organizational Affiliation
Cordis Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs