Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms (CEVARII)

Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Aneurysm, Infected; Inflammatory Abdominal Aortic Aneurysm; Aneurysm, Mycotic
• Intervention / Treatment: Procedure: Complex endovascular aortic repair (cEVAR)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Adverse Events (AEs) described in the protocol.	Follow-up timeframes - 1, 6, 12, 24, and 36 months	up to 36 months
All Cause Mortality	Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years	24 months
Continued Aortic sac growth.	Outcome measures include the number of participants who had continued sac growth (> 0.5 mm/6 month) despite appropriate reinterventions.	up to 24 months

Collaborators and Investigators

• Sponsor: CEVARII
• Collaborators: University of Colorado, Denver; University of Copenhagen; University of Iowa; University of Trieste; University of Colorado, Colorado Springs
• Investigators: Principal Investigator: MEL J Sharafuddin, MD, Memorial Hospital Central, University of Colorado Healthcare

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: April 20, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory; Aortic Aneurysm; Infected; Mycotic; INAA; IAA; Infective Native; Complex endovascular aortic repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aneurysm, Infected; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: 23 -1533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No