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Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Official Title:
Follow-up After Endovascular Repair of Abdominal Aortic AneurysmBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| N/A | Observational | 18 Years and older | University of California, San Francisco |
H53537-26003 NCT00488943 |
Recruiting |
Study Design:
Cohort, ProspectivePrincipal Investigator
Linda M. Reilly, M.D.
Professor of Surgery
Director, General Surgery Residency Program
Trial Summary
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.
Eligibility
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
Detailed 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.
Important
Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
For More Information
For questions about this trial or eligibility, please contact:
Johanna Garcia
Clinical Research Coordinator
UCSF Vascular Surgery
415-353-4379 Office
415-353-4370 Fax
Johanna.Garcia@ucsfmedctr.org
Leyla Herrera
Clinical Research Coordinator
UCSF Vascular Surgery
415-353-4367 Office
415-353-4370 Fax
Leyla.Herrera@ucsfmedctr.org