PMCF of Rotarex®S & Aspirex®S Catheters in Treating Throm... | NCT05071872

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

NCT05071872

Sponsor

Straub Medical AG

Status

Completed

Last Update Posted

Feb 9, 2023Actual

Enrollment

127Actual

Phase

Not provided

Conditions

Arteriovenous Graft Thrombosis

Interventions

Atherectomy/Thrombectomy

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2021Actual

Primary Completion Date

Jun 8, 2022Actual

Completion Date

Jun 8, 2022Actual

First Submitted Date

Sep 27, 2021

First Submission Date that Met QC Criteria

Sep 27, 2021

First Posted Date

Oct 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2023

Last Update Posted Date

Feb 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

127Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotarex®S		Treatment performed with Rotarex®S	Device: Atherectomy/Thrombectomy
Aspirex®S		Treatment performed with Aspirex®S	Device: Atherectomy/Thrombectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atherectomy/Thrombectomy	Device	Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft	Aspirex®S Rotarex®S

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Procedural success	defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel Heller, M.D.	Angiocentrum Příbram	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angiocentrum Příbram		Příbram			Czechia

Intervention Browse Module

MeSH Terms

ID	Term
D017073	Atherectomy
D017131	Thrombectomy

Ancestor Terms

ID	Term
D017130	Angioplasty
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures

Browse Leaves

Not provided

Browse Branches

Not provided