Talent Aortic Cuff Stent Graft System Compassionate Use Registry

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Abdominal aortic aneurysm
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Brief Title

Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Official Title

Compassionate Use of the TALENT Aortic Cuff in the Treatment of Patients Previously Treated With the AneuRx Stent Graft System With Sub-Optimal Stent Graft Outcomes

Brief Summary

      An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who
      have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for
      treatment with an AneuRx Aortic Cuff.

Detailed Description

      The primary purpose of this registry is to provide an endovascular means of treatment for
      those patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated
      stent graft and who are not deemed suitable candidates for treatment with an AneuRx Aortic
      Cuff. A sub-optimal outcome is defined as either a Type I or Type III endoleak and/or an
      inadequate seal zone (< 1 cm). For Registry purposes, a Type III endoleak will be defined as
      a proximal modular endoleak.

Study Type

Expanded Access

Condition

Abdominal Aortic Aneurysms

Intervention

TALENT Aortic Cuff Abdominal Stent Graft

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

Start Date

October 2002

Completion Date

April 2012

Primary Completion Date

July 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Patient >= 18 years of age

          -  Patient has a serious disease or condition

          -  No generally acceptable alternative for treating patient is available

          -  Patient has had the AneuRx stent graft system implanted >= 30 days

          -  Patient has suboptimal outcome with the AneuRx stent graft system as evidenced by one
             or more of the following:

          -  Type I endoleak

          -  Type III endoleak (Proximal, modular)

          -  Loss of seal zone

          -  Proximal aortic neck diameter >= 14mm and <= 30mm

          -  Angle between axis of the suprarenal aorta and aneurysm neck is <= 60 degrees

          -  Patient is able and willing to be available for 12,24,26,48 and 60 months
             post-procedure

        Exclusion Criteria:

          -  Patient is pregnant of lactating

          -  Arterial access cannot be crossed with a delivery system

          -  Excessive vessel tortuosity

          -  Excessive aortic calcification

          -  AneuRx stent graft system implanted within the last 30 days

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medtronic CardioVascular, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00604643

Organization ID

Investigational Plan #025

Responsible Party

Sponsor

Study Sponsor

Medtronic Endovascular

Study Sponsor

Medtronic CardioVascular, Study Director, Medtronic Cardiovascular

Verification Date

July 2015