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

Completed

• Conditions: Arteriovenous Graft Thrombosis
• Interventions: Device: Atherectomy/Thrombectomy

• Registration Number: NCT05071872
• Lead Sponsor: Straub Medical AG

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.

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study Start: 2021-10-06
• Study First Posted: 2021-10-08
• Status Verified: 2021-12
• Primary Completion: 2022-06-08
• Study Completion: 2022-06-08
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aspirex®S	Atherectomy/Thrombectomy	Treatment performed with Aspirex®S
Rotarex®S	Atherectomy/Thrombectomy	Treatment performed with Rotarex®S

Primary Outcome Measures

Name	Time	Method
Technical success	Day 1	defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter

Secondary Outcome Measures

Name	Time	Method
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
Procedural success	Day 1	defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment
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
Procedure-related Adverse events Rate	6 months	Procedure-related AEs as defined per ISO 14155
(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

Trial Locations

Locations (1)

Angiocentrum Příbram; 🇨🇿 Příbram, Czechia