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A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoAVF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoAVF Creation | Device | Subjects will have an endoAVF created using the WavelinQ EndoAVF System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Cannulation Success | The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period | 6-months post index procedure |
| Primary Patency | Subjects maintaining primary patency of the endoAVF | 6-months post index procedure |
| Device- and procedure-related serious adverse events (SAE) | Freedom from device-related or procedure-related SAEs | 30-days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Maturation | Defined by duplex ultrasound flow in the brachial artery of at least 500ml/min and outflow vein diameter ≥ 4mm | 2-weeks, 6-weeks, 6-months, and 24-months post index procedure |
| Functional Maturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal Anderson | Contact | +16028305413 | Crystal.Anderson@bd.com |
| Name | Affiliation | Role |
|---|---|---|
| Eric Peden, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Paul Kreienberg, MD | Albany Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Institute of Renal Research | Recruiting | La Jolla | California | 92037 | United States |
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Successful prescribed dialysis with 2-needle cannulation of the endoAVF for three continuous weeks
| 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure |
| Procedure Success | Successful endoAVF creation | Index procedure |
| Cannulation Success | Successful 2-needle endoAVF cannulation | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure |
| Primary Patency | Subjects maintaining primary patency of the endoAVF | 6-weeks, 3-, 12-, 18-, and 24-months post index procedure |
| Assisted Primary Patency | Subjects maintaining assisted primary patency of the endoAVF | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure |
| Secondary Patency | Subjects maintaining secondary patency of the endoAVF | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure |
| Functional Patency | Interval of time from endoAVF cannulation success to involuntary access abandonment | through 24-months |
| Functional Cannulation Success | The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period | 3-, 12-, 18-, and 24-months post index procedure |
| CVC Exposure/Use | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure |
| Procedural Adjunctive Procedures | Adjunctive procedures performed at the time of the index procedure | Index Procedure |
| Post Procedural Secondary Procedures | Number of secondary procedures conducted after the index procedure, broken down to identify interventions and second stage procedures | 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure |
| San Francisco Vein & Vascular | Recruiting | San Francisco | California | 94117 | United States |
|
| First Coast Cardiovascular Institute Pa | Recruiting | Jacksonville | Florida | 32256 | United States |
|
| Radiology and Imaging Specialists | Recruiting | Lakeland | Florida | 33801 | United States |
|
| Vascular and Spine Institute Inc | Active, not recruiting | Miami | Florida | 33156 | United States |
| Kidney Care and Transplant Services of NE | Recruiting | Springfield | Massachusetts | 01089 | United States |
|
| Kidney Care & Transplant Services of New England | Recruiting | West Springfield | Massachusetts | 01089 | United States |
|
| UMass Chan School of Medicine | Recruiting | Worcester | Massachusetts | 01655 | United States |
|
| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
|
| NC Nephrology | Completed | Raleigh | North Carolina | 27609 | United States |
| ProMedica Toledo Hospital | Recruiting | Toledo | Ohio | 43606 | United States |
|
| Butler Memorial Hospital | Recruiting | Butler | Pennsylvania | 16001 | United States |
|
| Vascular Institute of Chattanooga | Recruiting | Chattanooga | Tennessee | 37421 | United States |
|
| Bluff City Vascular | Recruiting | Memphis | Tennessee | 38104 | United States |
|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| Houston Methodist | Recruiting | Houston | Texas | 77030 | United States |
|
| Southern Adelaide Local Health Network | Recruiting | Bedford Park | South Australia | 5042 | Australia |
|
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001164 | Arteriovenous Fistula |
| 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 |
| 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 |
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