Juxtarenal Aortic Aneurysm | NCT06988345

Studies
Juxtarenal Aortic Aneurysm

NCT06988345

Sponsor

University Hospital Muenster

Status

Active, not recruiting

Last Update Posted

May 23, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Juxtarenal Aneurysms
Open Repair

Interventions

Not provided

Countries

Not provided

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

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 20, 2024

First Submission Date that Met QC Criteria

May 15, 2025

First Posted Date

May 23, 2025Actual

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

May 15, 2025

Last Update Posted Date

May 23, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Univ.-Prof. Dr. med. Alexander Oberhuber, Univ.-Prof. Dr. med., University Hospital MuensterPrincipal Investigator

Lead Sponsor

University Hospital MuensterOTHER

Collaborators

Name	Class
University Hospital Augsburg	OTHER
University Hospital, Aachen	OTHER
Goethe University	OTHER
University Hospital Heidelberg

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

All patients with a juxtarenal abdominal aortic aneurysm who underwent open aneurysm therapy between January 2010 and July 2020 were included retrospectively.

Detailed Description

Not provided

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality after 30 days postop	30 days after intervention
Acute renal failure	Acute renal failure postoperatively, defined by KDIGO criteria of AKI [22890468]	30 days after intervention

Secondary Outcomes

Measure	Description	Time Frame
Dialysis	Permanent dialysis required	during Follow up period, checked every year
Reinterventions	Rates of Reinterventions	during Follow up period, checked every year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a juxtarenal aneurysm (defined as infrarenal neck <10mm and clamping above at least one renal artery [31592091])
Open therapy with infrarenal (Anschluss)
>18 years

Exclusion Criteria:

Patients with an anastomosis above the renal arteries (e.g. including bypass to a renal artery)
Patients with supravisceral clamping
Patients with reconstruction of the aorta in the suprarenal area
Patients with connective tissue diseases (e.g. Marfan syndrome or Ehler Danlos syndrome)
Post-dissection aneurysms
Infected aneurysms
Conversions after endovascular therapy
Inflammatory aneurysms

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

All patients with a juxtarenal aneurysm who fulfill the inclusion criteria or do not fulfill the exclusion criteria may be included in this study

Sampling Method

Non-Probability Sample