Arteriovenous Graft Thrombosis
Conditions
Brief summary
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
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.
Interventions
DEVICEAtherectomy/Thrombectomy
Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft
Sponsors
Straub Medical AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male subject with a minimum age of 18 years 2. Treatment performed between 2013 and 2020 3. Occlusion in arteriovenous graft 4. For the Rotarex®S group: use of Rotarex®S Catheter 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Day 1 | defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful use of AV-Graft as dialysis access | Up to 14 days | Successful use of AV-Graft as dialysis access post-procedure on at least two occasions |
| Primary and Secondary Patency | 10 days, 1, 3 and 6 months | defined as ability to perform dialysis at 10 days, 1 month, 3 months and 6 months |
| (SAEs) Serious Adverse events Rate | 6 months | SAEs as defined per ISO 14155 |
| Procedural success | Day 1 | defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment |
| (ADEs) Adverse device effects Rate | 6 months | Adverse device effects (ADEs) as defined per ISO 14155 |
| (SADEs) Serious Adverse Device Effects Rate | 6 months | (SADEs) Serious Adverse Device Effects as defined per ISO 14155 |
| Procedure-related Adverse events Rate | 6 months | Procedure-related AEs as defined per ISO 14155 |
Countries
Czechia
Outcome results
None listed