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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Drug eluting angioplasty balloons |
|
| Control | Active Comparator | Non-drug eluting balloons |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting balloons | Device |
| ||
| Non drug eluting balloons |
| Measure | Description | Time Frame |
|---|---|---|
| Patency | Primary end point is a composite of one or more of :
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Defined as <30% residual stenosis using only the study balloon to which the patient was randomised | Time of baseline index intervention |
| Assisted technical success of balloon angioplasty |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| N E Anderson | Contact | +441216272000 |
| Name | Affiliation | Role |
|---|---|---|
| Robert Jones, Dr | University Hospital Birmingham NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust | Recruiting | Birmingham | West Midlands | B15 2TH | United Kingdom |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon
| At time of baseline index intervention |
| Successful use of fistula for dialysis | Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion | In the 12 months following baseline index intervention |
| Secondary patency of the access circuit | In the 12 months following baseline index intervention |