Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

Abdominal Aortic Aneurysm Clinical Trial

— CEVARII  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06380595
• Other study ID #: 23 -1533
• Status: Enrolling by invitation
• Start date: February 21, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: CEVARII
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Thoracoabdominal Aortic Aneurysm

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Healthcare	Aurora	Colorado

Sponsors (6)

Lead Sponsor	Collaborator
CEVARII	University of Colorado, Colorado Springs, University of Colorado, Denver, University of Copenhagen, University of Iowa, University of Trieste

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Aneurysm-related mortality (ARM)	Outcome measures include the number of participants who died 30 days after the procedure.	up to 30 days
Primary	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
Primary	Aortic rupture	Outcome measures include the number of participants who had aortic rupture.	up to 30 days.
Primary	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
Primary	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	Assessment of Adverse Events (AEs) described in the protocol.	Follow-up timeframes - 1, 6, 12, 24, and 36 months	up to 36 months
Secondary	All Cause Mortality	Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years	24 months
Secondary	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

External Links

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