Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

NCT06380595 | Enrolling By Invitation DMC

• 1 other identifier: 23 -1533
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Infected; Mycotic; Inflammatory; Aortic Aneurysm; INAA; IAA; Infective Native; Complex endovascular aortic repair

Outcome Measures

Primary Outcomes (8)

• Primary Graft Patency

  Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months

  up to 36 months

• Bowel Ischemia

  Bowel Ischemia requiring surgical resection/not resolving with medical therapy. Outcome measures include the number of Participants with bowel ischemia after surgery.

  30 days

• Presence of aortic aneurysm endoleak after surgery

  The technical repair success is defined as the exclusion of the aneurysm without Type I/III endoleak, and with preservation of at least the Superior Mesenteric Artery or the Celiac Artery. Outcome measures include the number of participants with type I endoleak, and the number of participants with type III endoleak.

  up to 30 days

• Aneurysm-related mortality (ARM)

  Outcome measures include the number of participants who died 30 days after the procedure.

  up to 30 days

• Conversion to Open Surgical Repair (OSR)

  Outcome measures include the number of participants whose cases converted from endovascular aortic aneurysm repair to open surgical repair.

  up to 30 days

• Aortic rupture

  Outcome measures include the number of participants who had aortic rupture.

  up to 30 days.

• Post-operative infection-related complication (IRC)

  Outcome measures include the number of participants who had a new post-operative infection-related complication (IRC) in treated aortic segments or endograft, new IRC in contiguous aortic segments, or persistent sepsis.

  up to 24 months

• The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies.

  Duration of antibiotics (in days) prescribed for Infective aortic aneurysm patients before and after the surgery. Duration of immunosuppressive drugs (in days) for inflammatory aortic aneurysm patients before and after the surgery

  up to 36 months

Secondary Outcomes (3)

• Assessment of Adverse Events (AEs) described in the protocol.

  up to 36 months

• All Cause Mortality

  24 months

• Continued Aortic sac growth.

  up to 24 months

Study Arms (2)

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.

Procedure: Complex endovascular aortic repair (cEVAR)

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.

Procedure: Complex endovascular aortic repair (cEVAR)

Interventions

Complex endovascular aortic repair (cEVAR) 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.

Infective Native Abdominal Aortic Aneurysms (INAA); Inflammatory aortic aneurysms (IAA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will consist of two separate cohorts: 1) inflammatory aortic aneurysms (IAA) and 2) infective native aortic aneurysms (INAA). Patients with confirmed IAA or INAA who were treated with complex endovascular techniques at participating centers will be included in the registry.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEVARII: lead
• University of Iowa: collaborator
• University of Colorado, Denver: collaborator
• University of Trieste: collaborator
• University of Copenhagen: collaborator
• University of Colorado, Colorado Springs: collaborator

Study Sites (1)

University of Colorado Healthcare

Aurora, Colorado, 80045, United States

Location

Related Links

• CEVARII research project information and updates
• CEVARII research project sign up link for interested sites.

MeSH Terms

Conditions

Aneurysm, Infected; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Infections; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• MEL J Sharafuddin, MD

  Memorial Hospital Central, University of Colorado Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Surgery and Radiology

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 24, 2024
• Study Start: February 21, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)