Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

NCT ID: NCT06380595

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-21

Study Completion Date

2026-03-31

Brief Summary

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Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533.

Detailed Description

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Infective Native and Inflammatory Aortic Aneurysms (INAA \& IAA) are rare, morbid conditions with unique challenges. INAA \& IAA share clinical and imaging similarities but differ significantly in pathophysiology, management, and prognosis. Open surgical repair of INAA \& IAA is technically challenging and associated with higher complications.

Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international consortium effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. CEVARII study is IRB approved with the number 23-1533.

Knowledge gained will help generate consensus on how to best manage patients with inflammatory and infective aortic aneurysms involving the visceral and thoracoabdominal aorta.

Conditions

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Inflammatory Abdominal Aortic Aneurysm Aneurysm, Infected Aneurysm, Mycotic Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infective Native Abdominal Aortic Aneurysms (INAA)

Infective native aortic aneurysms (INAA) are rare but highly morbid conditions that pose unique diagnostic and therapeutic challenges to the vascular surgeon.

Patients with confirmed NAA who were treated with complex endovascular techniques at participating centers will be included in the registry.

Complex endovascular aortic repair (cEVAR)

Intervention Type PROCEDURE

Complex endovascular aortic repair (cEVAR) collectively refers to the use of fenestrated/branched EVAR (f/bEVAR) or other EVAR variations allowing alternative visceral incorporation approaches, such as laser or radiofrequency (RF) fenestration or parallel endografts (snorkel, periscope, chimney or sandwich EVAR) to enable repair of perivisceral AAA (pvAAA), thoracoabdominal aortic aneurysms (TAAA), and aortic arch aneurysms.

Inflammatory aortic aneurysms (IAA)

Inflammatory aortic aneurysms (IAA) are rare but highly morbid conditions that pose unique diagnostic and therapeutic challenges to the vascular surgeon.

Patients with confirmed IAA who were treated with complex endovascular techniques at participating centers will be included in the registry.

Complex endovascular aortic repair (cEVAR)

Intervention Type PROCEDURE

Complex endovascular aortic repair (cEVAR) collectively refers to the use of fenestrated/branched EVAR (f/bEVAR) or other EVAR variations allowing alternative visceral incorporation approaches, such as laser or radiofrequency (RF) fenestration or parallel endografts (snorkel, periscope, chimney or sandwich EVAR) to enable repair of perivisceral AAA (pvAAA), thoracoabdominal aortic aneurysms (TAAA), and aortic arch aneurysms.

Interventions

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Complex endovascular aortic repair (cEVAR)

Complex endovascular aortic repair (cEVAR) collectively refers to the use of fenestrated/branched EVAR (f/bEVAR) or other EVAR variations allowing alternative visceral incorporation approaches, such as laser or radiofrequency (RF) fenestration or parallel endografts (snorkel, periscope, chimney or sandwich EVAR) to enable repair of perivisceral AAA (pvAAA), thoracoabdominal aortic aneurysms (TAAA), and aortic arch aneurysms.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients aged ≥ 18 years old with a diagnosis of inflammatory abdominal aortic aneurysm (IAA) or infective native aortic aneurysms (INAA), who have undergone complex endovascular aortic repair (cEVAR) are eligible for inclusion in this study.

Exclusion Criteria

* Suboptimal documentation of clinical, laboratory, and imaging findings
* Presence of prosthetic material (endograft or open graft material)
* Prior open or endovascular aortic repair
* Findings suspicious of secondary aorto-enteric or -bronchial fistulas.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

University of Trieste

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Colorado, Colorado Springs

OTHER

Sponsor Role collaborator

CEVARII

OTHER

Sponsor Role lead

Responsible Party

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Mel J. Sharafuddin, MD, FACS, FSIR

Clinical Professor of Surgery and Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MEL J Sharafuddin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Hospital Central, University of Colorado Healthcare

Locations

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University of Colorado Healthcare

Aurora, Colorado, United States

Site Status

Countries

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United States

Related Links

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https://cevarii.com/

CEVARII research project information and updates

https://redcap.link/CEVARII

CEVARII research project sign up link for interested sites.

Other Identifiers

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23 -1533

Identifier Type: -

Identifier Source: org_study_id

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