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The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoForce | AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | All device and/or procedure-related events and all major adverse events that reasonably suggest the involvement of the EndoForce and that require or result in any of the following: death, emergent surgery, events requiring hospitalization, events requiring percutaneous interventions, vascular access infection requiring treatment, significant bleeding, pseudoaneurysm and serious adverse events. EndoForce migration, inadequate seal and leakage will also be collected acutely and at each in-person follow-up visit. | 2 years |
| AVG Cumulative Patency | The percentage of subjects free from loss of access of the study graft for hemodialysis. | 2 years |
| AVG Primary Patency | The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency. | 2 years |
| Number of AVG Interventions to Maintain Patency | The number of AVG interventions until access abandonment or through study completion. | 2 years |
| Number of Participants with Acute Device Success | AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery. | Through end of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with end stage renal disease requiring hemodialysis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Zentgraf | Contact | 651-260-6673 | jzentgraf@phraxis.com |
| Name | Affiliation | Role |
|---|---|---|
| Ari Kramer, MD | Spartanburg Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Health Orangeburg | Not yet recruiting | Orangeburg | South Carolina | 29118 | United States |
IPD that underlie results in a publication
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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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| Spartanburg Regional Medical Center | Recruiting | Spartanburg | South Carolina | 29303 | United States |
|
| 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 |