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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expedial Vascular Access Graft | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Primary or assisted primary patency at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency | ||
| Overall adverse event rate | ||
| Time to first access |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular and General Surgery | Miami | Florida | 33125 | United States | ||
| Vascular Surgery Associates |
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| Time to hemostasis following needle withdrawal after dialysis |
| Baton Rouge |
| Louisiana |
| 70809 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Vascular Surgery | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| General Surgery | Bamberg | South Carolina | 29003 | United States |
| South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Peripheral Vascular Associates | San Antonio | Texas | 78206 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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