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A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aXess-E conduit | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aXess-E conduit | Device | The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency rate | Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. | 6 months |
| Freedom from device-related Serious Adverse Event (SAE) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation success rate | Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses. | 1 day, from moment of implant until end of procedure day |
| Primary patency rate |
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Inclusion Criteria:
Exclusion Criteria:
Intra-operative exclusion criteria:
1. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eliane Schutte | Contact | +31 40 751 7614 | clinical@xeltis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Santa Maria | Recruiting | Lisbon | Portugal |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. |
| 6, 12, 18, and 24 months |
| Primary assisted patency rate | Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the vascular access. | 6, 12, 18, and 24 months |
| Secondary patency rate | Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up). | 6, 12, 18, and 24 months |
| Functional patency rate | Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up). | 6, 12, 18, and 24 months |
| Time (expressed in months) to first intervention and to access abandonment | 24 months |
| Rate of access-related interventions required to achieve/maintain patency | 6, 12, 18, and 24 months |
| Freedom from device-related SAE | 12, 18, and 24 months |
| Rate of access site infections | 6, 12, 18, and 24 months |
| Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment | 24 months |
| Time to first cannulation | Assessed only in subjects who are already on dialysis at the time of implant. | 24 months |
| Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment | 12 months |
| Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti | Recruiting | Belgrade | Serbia |
|
| 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 |