Retrospective Post-Market Clinical Follow Up of Rotarex®S \& Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)
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.
Study Type
OBSERVATIONAL
Enrollment
127
Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft
Angiocentrum Příbram
Příbram, Czechia
Technical success
defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter
Time frame: Day 1
Procedural success
defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment
Time frame: 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
Time frame: Up to 14 days
Primary and Secondary Patency
defined as ability to perform dialysis at 10 days, 1 month, 3 months and 6 months
Time frame: 10 days, 1, 3 and 6 months
(SAEs) Serious Adverse events Rate
SAEs as defined per ISO 14155
Time frame: 6 months
Procedure-related Adverse events Rate
Procedure-related AEs as defined per ISO 14155
Time frame: 6 months
(ADEs) Adverse device effects Rate
Adverse device effects (ADEs) as defined per ISO 14155
Time frame: 6 months
(SADEs) Serious Adverse Device Effects Rate
(SADEs) Serious Adverse Device Effects as defined per ISO 14155
Time frame: 6 months
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