Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

N/AEnrolling By InvitationNCT06380595

CEVARII220 enrolled

Overview

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.

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

220

Conditions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Colorado Healthcare

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Primary Graft Patency

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

Time frame: 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.

Time frame: 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.

Time frame: up to 30 days

Aneurysm-related mortality (ARM)

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

Time frame: 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.

Time frame: up to 30 days

Aortic rupture

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

Time frame: 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.

Time frame: 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

Time frame: up to 36 months

Secondary Outcomes

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

Follow-up timeframes - 1, 6, 12, 24, and 36 months

Time frame: up to 36 months

All Cause Mortality

Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years

Time frame: 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.

Time frame: up to 24 months

Data from ClinicalTrials.gov

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