CEVARII
Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)
Sponsor study identifier
observational
220
1 country
1
Study Start
February 21, 2024
Actual (reported)Primary Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2024
Actual (reported)March 1, 2024
Actual (reported)April 24, 2024
Actual (reported)March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University of Colorado Healthcare
Aurora, Colorado, 80045, United States
MEL J Sharafuddin, MD
Memorial Hospital Central, University of Colorado Healthcare
First Submitted
March 1, 2024
First Posted
April 24, 2024
Study Start
February 21, 2024
Actual (reported)Primary Completion
March 2025
Estimated (date passed)PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
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
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
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 24, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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