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The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular AVF (EndoAVF) | Experimental | The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovasccular AVF (EndoAVF) | Device | The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Access Functionality | The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period. | 6 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Ebner, MD | Italian Hosptial, Asuncion, Paraguay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Italian Hospital | Asunción | 1001-1925 | Paraguay |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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 |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |