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This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VasQ device implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VasQ | Device | VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency of AV fistula | Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention | 6 months post AVF creation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noam Zilberman | Laminate Medical Technologies Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Mutualiste Montsouris | Paris | 75014 | France | |||
| Universitätsklinikum Augsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27079670 | Background | Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Augsburg |
| 86156 |
| Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Königin Elisabeth Krankenhaus Herzberge | Berlin | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09113 | Germany |
| University Hospital Cologne | Cologne | 50937 | Germany |
| Universitaetsklinikum Jena | Jena | Germany |
| Klinikum Ernst von Bergmann gemeinnützige GmbH | Potsdam | 14467 | Germany |
| Harzklinikum Dorothea Christiane Erxleben | Wernigerode | Germany |
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| 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 |
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