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EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study) (EVAR-SE)

Primary Purpose

Abdominal Aortic Aneurysm, Endoleak

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Coil embolization of aneurysm sac
Sponsored by
Univ.-Prof. Dr. med. Hans-Henning Eckstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years Infrarenal AAA ≥50 mm maximum diameter Indication for EVAR within IFU of company Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or <40% thrombus at largest AAA diameter Exclusion Criteria: Ruptured AAA Fenestrated or branched EVAR Concomitant iliac artery aneurysm Non-ability to adhere to the FU protocol Lack of consent Pregnancy

Sites / Locations

  • Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre ChirurgieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EVAR with SE

standard EVAR

Arm Description

Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.

Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.

Outcomes

Primary Outcome Measures

Type II Endoleak at 12 months after procedure
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A

Secondary Outcome Measures

Type II Endoleak during follow up
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Type II Endoleak during follow up
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Type II Endoleak during follow up
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Re-intervention
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
Type I or III Endoleak
Occurrence of any EL Type I or III
AAA morphology
Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0
AAA morphology
Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0
AAA rupture
Rate of AAA rupture 12 months after EVAR treatment
Mortality
Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment
life quality
Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment

Full Information

First Posted
December 7, 2022
Last Updated
May 11, 2023
Sponsor
Univ.-Prof. Dr. med. Hans-Henning Eckstein
Collaborators
Technical University of Munich, St. Josefs-Hospital Wiesbaden GmbH, University Hospital Augsburg, University Hospital Carl Gustav Carus
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1. Study Identification

Unique Protocol Identification Number
NCT05665101
Brief Title
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)
Acronym
EVAR-SE
Official Title
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Univ.-Prof. Dr. med. Hans-Henning Eckstein
Collaborators
Technical University of Munich, St. Josefs-Hospital Wiesbaden GmbH, University Hospital Augsburg, University Hospital Carl Gustav Carus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture. Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm, Endoleak
Keywords
Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EVAR with SE
Arm Type
Experimental
Arm Description
Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.
Arm Title
standard EVAR
Arm Type
No Intervention
Arm Description
Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.
Intervention Type
Procedure
Intervention Name(s)
Coil embolization of aneurysm sac
Intervention Description
Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
Primary Outcome Measure Information:
Title
Type II Endoleak at 12 months after procedure
Description
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Type II Endoleak during follow up
Description
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Time Frame
2-4 days
Title
Type II Endoleak during follow up
Description
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Time Frame
30 days
Title
Type II Endoleak during follow up
Description
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Time Frame
6 months
Title
Re-intervention
Description
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
Time Frame
12 months
Title
Type I or III Endoleak
Description
Occurrence of any EL Type I or III
Time Frame
12 months
Title
AAA morphology
Description
Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0
Time Frame
12 months
Title
AAA morphology
Description
Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0
Time Frame
12 months
Title
AAA rupture
Description
Rate of AAA rupture 12 months after EVAR treatment
Time Frame
12 months
Title
Mortality
Description
Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment
Time Frame
12 months
Title
life quality
Description
Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Infrarenal AAA ≥50 mm maximum diameter Indication for EVAR within IFU of company Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or <40% thrombus at largest AAA diameter Exclusion Criteria: Ruptured AAA Fenestrated or branched EVAR Concomitant iliac artery aneurysm Non-ability to adhere to the FU protocol Lack of consent Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans-Henning Eckstein, MD,PhD
Phone
0049-894140
Ext
2167
Email
gefaesschirurgie@mri.tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph M Knappich, MD
Phone
0046-894140
Ext
8082
Email
christoph.knappich@mri.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Henning Eckstein, MD,PhD
Organizational Affiliation
Technical University Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Henning Eckstein, Univ.-Prof.Dr.med.
Phone
0049894140
Ext
2167
Email
gefaesschirurgie@mri.tum.de
First Name & Middle Initial & Last Name & Degree
Christoph Knappich, PD Dr. med.
Phone
0049894140
Ext
80802
Email
christoph.knappich@mri.tum.de
First Name & Middle Initial & Last Name & Degree
Hans-Henning Eckstein, Prof.Dr.med.
First Name & Middle Initial & Last Name & Degree
Christoph Knappich, PD Dr.med.
First Name & Middle Initial & Last Name & Degree
Michael Kallmayer, Dr. med.
First Name & Middle Initial & Last Name & Degree
Heiko Wendorff, Dr. med.
First Name & Middle Initial & Last Name & Degree
Maria Del Pilar Ortega Carrillo, Dr. med.
First Name & Middle Initial & Last Name & Degree
Felix Kirchhoff, Dr. med.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

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