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Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Abdominal Aortic Aneurysm

Treatments

Device: AAA Endovascular Bifurcated Stent-Graft

Study type

Observational

Funder types

Other

Identifiers

NCT00488943
H53537-26003

Details and patient eligibility

About

To collect and analyze clinical follow-up data which can be used to assess the safety, efficacy, and durability of endovascular AAA repair with Zenith and Chuter-Gianturco stent-grafts.

Full description

We propose to analyze the data collected for clinical purposes in 453 patients who already underwent endovascular AAA repair at UCSF and SFVA, and others who will undergo this operation in the future. Most of these patients have now passed the 2-year follow-up required by the original protocol, all continue to be followed for clinical purposes, using the same studies, the same data forms and the same schedule as before, because studies of various devices of this type have shown that the potential for late problems requires continuing scrutiny of stent-graft structure and function, as a basis for timely re-intervention.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
  • treatment of AAA with Zenith Stent-Graft

Exclusion criteria

  • Pregnant
  • Life expectancy less than two years
  • Less than 18 years of age
  • Unwilling to comply with clinical follow-up schedule
  • Inability or refusal to give informed consent

Trial contacts and locations

2

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Central trial contact

Linda M Reilly, MD

Data sourced from clinicaltrials.gov

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