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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06380595
Other study ID # 23 -1533
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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