Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Feasibility of the Vessel Restoration System for AVF
A study of the safety and feasibility of the Vessel Restoration System for AVF to promote the physiologic and functional maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients with Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alucent VRS for Treatment of Atherosclerotic Lesions | Experimental | Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alucent Vessel Restoration System for AVF | Combination Product | Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| AVF Maturation | Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points | 2 weeks to 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Ecklund, MPH | Contact | 3857722300 | kecklund@alucentbiomedical.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
Not provided
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
A prospective, single-arm, multicenter, open-label study of the VRS-AVF for use as adjunctive therapy in the surgical creation of an end-to-side brachiocephalic (BC) AVF.
Not provided
Not provided
Not provided
Not provided
| Prince of Wales | Recruiting | Randwick | New South Wales | 2031 | Australia |
|
| Royal North Shore Hospital & North Shore Private | Recruiting | Saint Leonards | New South Wales | 2065 | Australia |
|
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
|
| Flinders Medical Center | Recruiting | Bedford Park | South Australia | 5042 | Australia |
|
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| Northern Health | Recruiting | Richmond | Victoria | 3121 | Australia |
|
| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
|
| Poznan University of Medical Sciences | Recruiting | Lublin | Poland |
| Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej | Recruiting | Warsaw | Poland |
| Lower Silesia Center of Heart Diseases MEDINet | Recruiting | Wroclaw | Poland |
| Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej | Recruiting | Zielona Góra | Poland |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |