Endurant for Challenging Anatomy: Global Experience Registry | NCT01810250

Studies
Endurant for Challenging Anatomy: Global Experience Registry

NCT01810250

Sponsor

Catharina Ziekenhuis Eindhoven

Status

Completed

Last Update Posted

Dec 26, 2023Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Abdominal Aortic Aneurysms With Challenging Anatomy

Interventions

Endurant Stent Graft

Countries

Netherlands

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 2023

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

Nov 2012

Primary Completion Date

Jan 2018Actual

Completion Date

May 2023Actual

First Submitted Date

Feb 12, 2013

First Submission Date that Met QC Criteria

Mar 11, 2013

First Posted Date

Mar 13, 2013Estimated

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

Dec 20, 2023

Last Update Posted Date

Dec 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.

This study aims at answering two major questions:

Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?

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

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominal Aortic Aneurysm (Challenging anatomy)		Endovascular aneurysm repair	Device: Endurant Stent Graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurant Stent Graft	Device		Abdominal Aortic Aneurysm (Challenging anatomy)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical success	Freedom from: Increase of AAA diameter > 5 mm (1 month measurement as baseline) Type I&III endoleaks Aneurysm rupture Conversion to surgery Stent graft migration (>10mm) resulting in SAE or reintervention Stent graft occlusion	12 months

Secondary Outcomes

Measure	Description	Time Frame
Helath Related Quality of Life Scores	EQ-5D VAS EQ-5D index	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years or minimum age as required by local regulations
Indication for elective EVAR
Challenging AAA anatomy
Signed informed consent form

Exclusion Criteria:

Subjects with intolerance to contrast media
Chimneys or fenestrated device procedures
High probability of non-adherence to physician's follow-up requirements
Current participation in a concurrent trial that may confound study results

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

Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements:

Proximal necks 5 - 10mm in combination with < 60 degrees infrarenal AND < 45 degrees suprarenal angulation
Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND < 60 degrees suprarenal angulation OR in combination with < 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation
Proximal necks > 15mm in combination with 75 degrees - 90 degrees infrarenal AND < 75 degrees suprarenal angulation OR in combination with < 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation

Sampling Method

Probability Sample