PMCF of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft

Study Overview
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Brief Summary
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Retrospective Post-Market Clinical Follow Up of Rotarex®S & Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)

Detailed Description
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To evaluate the safety, technical performance, and clinical efficacy of the Rotarex®S & Aspirex®S Catheters as a stand-alone and adjunctive therapy for the treatment of acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) in accordance with Rotarex®S & Aspirex®S Catheters intended use.

Official Title
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Retrospective Post-Market Clinical Follow Up of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft for Dialysis Access (Artificial Bypass)

Conditions
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Arteriovenous Graft Thrombosis

Intervention / Treatment
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* Device: Atherectomy/Thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male subject with a minimum age of 18 years Treatment performed between 2013 and 2020 Occlusion in arteriovenous graft For the Rotarex®S group: use of Rotarex®S Catheter For the Aspirex®S group: use of Aspirex®S Catheter Exclusion Criteria: 1. Subjects not appropriate for this study according to the opinion of the principal investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotarex®S<br>Treatment performed with Rotarex®S | Device: Atherectomy/Thrombectomy<br>* Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft<br>|
| Aspirex®S<br>Treatment performed with Aspirex®S | Device: Atherectomy/Thrombectomy<br>* Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment | Day 1 | 
| Successful use of AV-Graft as dialysis access | Successful use of AV-Graft as dialysis access post-procedure on at least two occasions | Up to 14 days | 
| Primary and Secondary Patency | defined as ability to perform dialysis at 10 days, 1 month, 3 months and 6 months | 10 days, 1, 3 and 6 months | 
| (SAEs) Serious Adverse events Rate | SAEs as defined per ISO 14155 | 6 months | 
| Procedure-related Adverse events Rate | Procedure-related AEs as defined per ISO 14155 | 6 months | 
| (ADEs) Adverse device effects Rate | Adverse device effects (ADEs) as defined per ISO 14155 | 6 months | 
| (SADEs) Serious Adverse Device Effects Rate | (SADEs) Serious Adverse Device Effects as defined per ISO 14155 | 6 months |