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OpenTrials
Completed

NCT Number: NCT05071872

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

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

Completed

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Key information

Conditions

Arteriovenous Graft Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angiocentrum Příbram

Příbram, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Subjects not appropriate for this study according to the opinion of the principal investigator

Treatment and study plan

Atherectomy/Thrombectomy

Device

Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft

Primary outcomes

  1. Technical success

    Time frame: Day 1

    defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter

Secondary outcomes

  1. Procedural success

    Time frame: Day 1

    defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment

  2. Successful use of AV-Graft as dialysis access

    Time frame: Up to 14 days

    Successful use of AV-Graft as dialysis access post-procedure on at least two occasions

  3. Primary and Secondary Patency

    Time frame: 10 days, 1, 3 and 6 months

    defined as ability to perform dialysis at 10 days, 1 month, 3 months and 6 months

  4. (SAEs) Serious Adverse events Rate

    Time frame: 6 months

    SAEs as defined per ISO 14155

  5. Procedure-related Adverse events Rate

    Time frame: 6 months

    Procedure-related AEs as defined per ISO 14155

  6. (ADEs) Adverse device effects Rate

    Time frame: 6 months

    Adverse device effects (ADEs) as defined per ISO 14155

  7. (SADEs) Serious Adverse Device Effects Rate

    Time frame: 6 months

    (SADEs) Serious Adverse Device Effects as defined per ISO 14155

Sponsors and collaborators

Lead sponsor

Straub Medical AG

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2021
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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