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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233688
• Other study ID #: P01-4601
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2005
• Last updated: April 30, 2009
• Start date: November 2001
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2009
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• QUANTUM LP™ STENT GRAFT SYSTEM
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

Procedure:
• Open surgical repair
Open surgical repair

Locations

Country	Name	City	State
United States	Newark Beth Israel Medical Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One year	Yes
Primary	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		One year	Yes
Secondary	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).		30 days, 6 mo, and annually up to five years	Yes
Secondary	To compare the rate and amount of blood products used in the stent graft procedure to open surgery.		At procedure	No