Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

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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

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Official Title

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Brief Summary

      The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm
      exclusion using an endovascular prosthesis.

Detailed Description

      This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in
      high-risk patients. The purpose of this study is to determine whether this endovascular
      prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in
      patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will
      be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram,
      intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The
      endovascular prosthesis is placed in the operating room under regional or general anesthesia
      and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1
      month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical
      exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.

Study Type

Interventional

Primary Outcome

Freedom From Aneurysm Rupture

Condition

Abdominal Aortic Aneurysm

Intervention

Endovascular Aneurysm Repair

Study Arms / Comparison Groups

 Endovascular Aneurysm Repair
Description:  Investigational stent-graft implant to exclude aneurysm

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

401

Start Date

September 1998

Completion Date

October 2017

Primary Completion Date

October 2017

Eligibility Criteria

        Inclusion Criteria:

          -  The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape,
             history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm

          -  Anticipated mortality greater than 10 percent with conventional surgery

          -  Life expectancy greater than 2 years

          -  Suitable arterial anatomy

          -  Absence of systemic disease or allergy that precludes an endovascular repair

          -  Capable of giving informed consent and willingness to comply with the follow-up
             schedule

        Exclusion Criteria:

          -  Pregnancy

          -  History of anaphylactic reaction to contrast material with an inability to properly
             prophylax the patient appropriately

          -  Allergy to stainless steel or polyester

          -  Unwilling to comply with the follow-up schedule

          -  Serious or systemic groin infection

          -  Coagulopathy, other than coumadin therapy

          -  Inability to give informed consent

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthew J Eagleton, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00583414

Organization ID

G980198

Secondary IDs

IRB 3264

Responsible Party

Principal Investigator

Study Sponsor

The Cleveland Clinic

Study Sponsor

Matthew J Eagleton, MD, Principal Investigator, The Cleveland Clinic

Verification Date

January 2019