NCT05071872

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

February 9, 2023

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

September 27, 2021

Last Update Submit

February 8, 2023

Conditions

Arteriovenous Graft Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Technical success

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

    Day 1

Secondary Outcomes (7)

  • Procedural success

    Day 1

  • Successful use of AV-Graft as dialysis access

    Up to 14 days

  • Primary and Secondary Patency

    10 days, 1, 3 and 6 months

  • (SAEs) Serious Adverse events Rate

    6 months

  • Procedure-related Adverse events Rate

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Rotarex®S

Treatment performed with Rotarex®S

Device: Atherectomy/Thrombectomy

Aspirex®S

Treatment performed with Aspirex®S

Device: Atherectomy/Thrombectomy

Interventions

Atherectomy/ThrombectomyDEVICE

Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft

Aspirex®SRotarex®S

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) treated with either Rotarex®S Catheter nor Aspirex®S Catheter

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angiocentrum Příbram

Příbram, Czechia

Location

MeSH Terms

Interventions

AtherectomyThrombectomy

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Samuel Heller, M.D.

    Angiocentrum Příbram

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 8, 2021

Study Start

October 6, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

February 9, 2023

Record last verified: 2021-12

Locations

CZ(1)