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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00332-39 | Other Identifier | RCB number |
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Inclusion curve too slow.
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The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon |
|
| Standard arm | Active Comparator | Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutting balloon angioplasty | Procedure | Angioplasty of fistula stenosis using a cutting balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | Primary patency following a first angioplasty of a first stenose in the affected zone. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of early re-stenoses | stenosis defined as lumen diameter < 2mm | 3 months |
| Number of re-stenoses | Stenosis defined as lumen diameter < 2mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Picard, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| Angioplasty | Procedure | Angioplasty of fistula stenosis using a non-cutting balloon |
|
| 12 months |
| Total days in hospital | The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities. | 12 months |
| Number of stents used | The total number of stents placed between the study angioplasty and the end-of-study visit. | 12 months |
| Total number of venous thromboses | Total number of venous thromboses between study angioplasty and end-of-study visit | 12 months |
| Direct medical costs (€) | 12 months |
| Indirect costs (€) | 12 months |
| Questionnaire KDQOL | 12 months |
| Questionnaire SF36 | 12 months |
| Questionnaire KDQOL | 3 months |
| Questionnaire KDQOL | 6 months |
| Questionnaire SF36 | 3 months |
| Questionnaire SF36 | 6 months |
| Fistula quality (cm*ml/min) | cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min) | Baseline |
| Fistula quality (cm*ml/min) | cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min) | 6 months |
| Fistula quality (cm*ml/min) | cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min) | 12 months |
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | Baseline |
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | 6 months |
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | 12 months |
| Presence/absence of complications associated with the angioplasty | Day of intervention |
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | 3 months |
| Presence/absence of complications since the last visit | 6 months |
| Presence/absence of complications since the last visit | 12 months |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |