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Talent Aortic Cuff Stent Graft System Compassionate Use Registry

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ClinicalTrials.gov Identifier: NCT00604643
Recruitment Status : No longer available
First Posted : January 30, 2008
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms Device: TALENT Aortic Cuff Abdominal Stent Graft

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
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
Study Start Date : October 2002
Actual Primary Completion Date : July 2008
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources


Intervention Details:
    Device: TALENT Aortic Cuff Abdominal Stent Graft
    Endovascular Aneurysm Repair

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604643


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Sponsors and Collaborators
Medtronic Endovascular
Investigators
Study Director: Medtronic CardioVascular Medtronic Cardiovascular

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604643     History of Changes
Other Study ID Numbers: Investigational Plan #025
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

Keywords provided by Medtronic Endovascular:
Abdominal Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Endograft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases