An observational study in Inflammatory Abdominal Aortic Aneurysm, Aneurysm, Infected and Aneurysm, Mycotic, sponsored by CEVARII. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by CEVARII · Observational
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's planned enrollment of 220 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →This is the only study on the registry with CEVARII as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
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:
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) 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.
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
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
Plan to share: No
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Aneurysm, Infected