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

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Safety Study for the Treatment of Abdominal Aortic Aneurysms Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair Sodium Fluoride Imaging of Abdominal Aortic Aneurysms Biomarker Profiling in Abdominal Aortic Aneurysm Patients Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION) Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care ACZ885 for the Treatment of Abdominal Aortic Aneurysm Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT Intact Abdominal Aortic Aneurysm Repair in Portugal The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study

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

Brief Summary

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

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 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).

Condition

Abdominal Aortic Aneurysm

Intervention

QUANTUM LP™ STENT GRAFT SYSTEM

Study Arms / Comparison Groups

 1
Description:  QUANTUM LP™ STENT GRAFT SYSTEM

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

300

Start Date

November 2001

Completion Date

April 2009

Primary Completion Date

December 2004

Eligibility 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 /= 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 /= 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

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

H. Wayne Hutman, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00233688

Organization ID

P01-4601

Study Sponsor

Cordis Corporation

Study Sponsor

H. Wayne Hutman, MD, Study Director, Cordis Corporation

Verification Date

April 2009