Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)

Official Title

An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm

Brief Summary

      The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral
      AAA device and its Delivery System compared to open surgical repair for the treatment of
      Abdominal Aortic Aneurysm (AAA).

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.

Secondary Outcome

 · Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.

Condition

Abdominal Aortic Aneurysm

Intervention

Cordis AAA Bilateral Device

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

29

Start Date

December 1999

Completion Date

February 2006

Eligibility Criteria

        Inclusion Criteria:

        - Anatomic (stent-graft)

        Aortic Aneurysm Diameter

          -  > 4.5 cm

          -  Those aortic aneurysms < 4.5 cm that are at least 1.5 times the diameter of the aorta
             with a size increase of 5 mm or greater over a six month period will also be included
             for possible treatment.

          -  Aorto-iliac aneurysms in which the aortic aneurysm is < 4.5 cm but the iliac artery
             aneurysms are > 3.0 cm in diameter or there is evidence of recent expansion (5 mm or
             greater over a six month period) in iliac aneurysms < 3.0 cm.

          -  Saccular aortic aneurysms > 3.0 cm.

        Aortic Neck

          -  Diameter > 17 mm and < 28 mm (Phase I)

          -  Diameter > 14 mm and < 28 mm (Phase II)

        Angulation Neck Length < 45° > 15 mm <60° > 25 mm

        Iliac Arteries

          -  Diameter > 8 mm and < 18 mm (Phase I and Phase II)

          -  At least one common iliac artery with a cuff > 15 mm.

        Diameter Aortic Neck Common Iliac 26-28 mm 13-18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9-15 mm
        17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm

        *NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range
        (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs).

        Anatomic (surgical controls)

        · Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size
        requirements for anatomic inclusion criteria.

        Aortic Aneurysm Diameter

          -  > 4.5 cm

          -  Those aortic aneurysms <4.5 cm that are at least 1.5 times the diameter of the aorta
             with a size increase of 5 mm or greater over a six month period will also be included
             for possible treatment.

          -  Aorto-iliac aneurysm in which the aortic aneurysm is <4.5 cm but the iliac artery
             aneurysm are >3.0 cm in diameter or there is evidence of recent expansion (5 mm or
             greater over a six month period) in iliac aneurysms <3.0 cm.

          -  Saccular aortic aneurysms > 3.0 cm.

          -  Clinical (stent-graft)

          -  Males and non-pregnant females > 40 years of age.

          -  Clinical (surgical controls)

        Surgical control patients will be required to meet all of the above-stated stent-graft
        clinical inclusion criteria.

        Exclusion Criteria:

        Anatomic (stent-graft)

        Aortic Aneurysm Diameter

        · < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a
        size increase of 5 mm or greater within a six month period.

        Aorto-iliac Aneurysms

          -  < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six
             month period).

          -  The iliac portion of the aneurysm extending to the bifurcation bilaterally which would
             necessitate covering both internal iliac arteries with the device.

        Aortic Neck

          -  Diameter < 17 mm and > 28 mm (Phase I)

          -  Diameter < 14 and >28 (Phase II)

          -  Thrombus lined

          -  Highly calcified

               -  NOTE: See inclusion criteria for length below the renals and degree of
                  angulation.

        Iliac Arteries

          -  < 8 mm and > 18 mm (native) (Phase I and Phase II)

          -  Highly calcified (common)

          -  Neither common iliac artery with a cuff > 15 mm.

               -  NOTE: See inclusion criteria for aortic neck and iliac artery diameters.

        Anatomic (surgical controls)

        · Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size
        requirements for anatomic exclusion criteria.

        Aortic Aneurysm Diameter

        · < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a
        size increase of 5 mm or greater within a six month period.

        Aorto-Iliac Aneurysms

          -  < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six
             month period).

          -  The iliac portion of the aneurysm extending to the bifurcation bilaterally which would
             necessitate surgically covering both internal iliac arteries.

        Clinical (stent-graft)

          1. Ruptured abdominal aortic aneurysm.

          2. Renal insufficiency - creatinine level > 2.5 mg/dl.

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Marin, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00235118

Organization ID

P98-4601

Study Sponsor

Cordis Corporation

Study Sponsor

Michael Marin, MD, Principal Investigator, MOUNT SINAI HOSPITAL

Verification Date

October 2005