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This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AV fistula with VasQ | Experimental | Implant VasQ over AV fistula |
|
| AV fistula | No Intervention | AV fistula without any adjunct device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VasQ | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoint: Percentage of AVF physiologically matured | Successful physiological maturation was defined by a minimum of 5 mm cephalic vein diameter with volume outflow greater than 500 mL/min confirmed by color duplex spectral analysis | 3 months |
| Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | 52621 | Israel | |||
| Southmead Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31447072 | Derived | Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M, Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53. doi: 10.1053/j.ajkd.2019.05.023. Epub 2019 Aug 22. |
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| 6 months |
| Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound | 1, 3, and 6 months |
| Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions | 6 months |
| Bristol |
| BS10 5NB |
| United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| St George's Healthcare | London | United Kingdom |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| 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 |
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