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Sponsored by: |
LeMaitre Vascular |
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Information provided by: | LeMaitre Vascular |
ClinicalTrials.gov Identifier: | NCT00131872 |
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
Condition | Intervention | Phase |
---|---|---|
End Stage Renal Disease |
Device: Expedial Vascular Access Graft |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts |
Estimated Enrollment: | 172 |
Study Start Date: | March 2004 |
Study Completion Date: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Vascular and General Surgery | |
Miami, Florida, United States, 33125 | |
United States, Louisiana | |
Vascular Surgery Associates | |
Baton Rouge, Louisiana, United States, 70809 | |
United States, New York | |
Vascular Surgery | |
Bronx, New York, United States, 10461 | |
Montefiore Medical Center | |
Bronx, New York, United States, 10461 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, South Carolina | |
South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System | |
Greenville, South Carolina, United States, 29605 | |
General Surgery | |
Bamberg, South Carolina, United States, 29003 | |
United States, Texas | |
Peripheral Vascular Associates | |
San Antonio, Texas, United States, 78206 |
Study ID Numbers: | 00168 |
Study First Received: | August 17, 2005 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00131872 |
Health Authority: | United States: Food and Drug Administration |
vascular access graft hemodialysis dialysis end stage renal disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |