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The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.
This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoAVF | Experimental | The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: | The percentage of patients with fistula maturation/usability defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR patient was dialyzed using 2 needles. | within 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation | within 3 months |
| EndoAVF-related Re-intervention Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charmaine Lok, MD, MSC, FRCPC | The Toronto General Hospital | Principal Investigator |
| Dheeraj Rajan, MD, BSc, FRCPC, FSIR | The Toronto General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia | ||
| Alfred Hospital |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| D005402 | Fistula |
| D007674 | Kidney Diseases |
| D007676 | Kidney Failure, Chronic |
| D014570 | Urologic Diseases |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) will be calculated at 3, 6 and 12 months post index procedure.
| 3, 6 and 12 months |
| Primary Patency | Time from successful endoAVF creation to the first intervention designed to address thrombosis or stenosis, assist in maturation or cannulation of endoAVF, or endoAVF abandonment. | 3, 6 and 12 months |
| Cumulative Patency | Time from creation to the abandonment of endoAVF (censor patients with renal transplant) | 3, 6 and 12 months |
| Functional Usability | 2-needle cannulation of the endoAVF for prescribed dialysis in ≥ 2/3 of dialysis sessions over a 4 consecutive week period within 12 months of endoAVF creation. | 4 weeks post procedure, up to 12 months |
| Melbourne |
| Victoria |
| 3181 |
| Australia |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| QE II Health Sciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Lakeridge Health Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| The Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| CHUM, Notre-Dame Hospital | Montreal | Quebec | H2L 4M1 | Canada |
| Auckland City Hospital | Grafton | 1142 | New Zealand |
| 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 |
| D020763 | Pathological Conditions, Anatomical |