Inflammatory Abdominal Aortic AneurysmCEVARIINCT06380595
Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms
An observational study of Inflammatory Abdominal Aortic Aneurysm and Aneurysm, Infected, run by CEVARII at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Abdominal Aortic Aneurysm, Aneurysm, Infected, Aneurysm, Mycotic
- What is being tested?
- Complex endovascular aortic repair (cEVAR)
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Healthcare
Aurora, Colorado, 80045
About this study
Official title: Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)
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.
Read the detailed 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.
- Conditions
- Inflammatory Abdominal Aortic Aneurysm, Aneurysm, Infected, Aneurysm, Mycotic, Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- Being tested
- Complex endovascular aortic repair (cEVAR)
- Keywords
- Infected, Mycotic, Inflammatory, Aortic Aneurysm, INAA, IAA, Infective Native, Complex endovascular aortic repair
- Medical subject headings
- Aneurysm, Infected, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex endovascular aortic repair (cEVAR)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Infective Native Abdominal Aortic Aneurysms (INAA) | 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. Receives: Procedure: Complex endovascular aortic repair (cEVAR) | |
| Inflammatory aortic aneurysms (IAA) | 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. Receives: Procedure: Complex endovascular aortic repair (cEVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Graft Patency
Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Measured: 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.
Measured: 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.
Measured: up to 30 days
Aneurysm-related mortality (ARM)
Outcome measures include the number of participants who died 30 days after the procedure.
Measured: 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.
Measured: up to 30 days
Aortic rupture
Outcome measures include the number of participants who had aortic rupture.
Measured: 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.
Measured: 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
Measured: up to 36 months
Secondary outcomes (3)
Assessment of Adverse Events (AEs) described in the protocol.
Follow-up timeframes - 1, 6, 12, 24, and 36 months
Measured: up to 36 months
All Cause Mortality
Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years
Measured: 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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start21 Feb 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEVARII
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Colorado, Denver, University of Trieste, University of Copenhagen, University of Colorado, Colorado Springs
- Responsible party
- Principal investigator, Mel J. Sharafuddin, MD, FACS, FSIR, University of Colorado, Colorado Springs
- Investigators
- MEL J Sharafuddin, MD, Principal investigator, Memorial Hospital Central, University of Colorado Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380595
- Sponsor's protocol ID
- 23 -1533
- Acronym
- CEVARII
- Status last verified
- Apr 2024
- First submitted
- 1 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)
- ClinicalTrials.gov ID
- NCT06380595
- Acronym / sponsor ID
- CEVARII / 23 -1533
- Conditions
- Inflammatory Abdominal Aortic Aneurysm, Aneurysm, Infected, Aneurysm, Mycotic, Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- Keywords
- Infected, Mycotic, Inflammatory, Aortic Aneurysm, INAA, IAA, Infective Native, Complex endovascular aortic repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- CEVARIIUniversity, hospital or other
- Collaborators
- University of Iowa, University of Colorado, Denver, University of Trieste, University of Copenhagen, University of Colorado, Colorado Springs
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infective Native Abdominal Aortic Aneurysms (INAA) | – | Procedure: Complex endovascular aortic repair (cEVAR)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) | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Infective Native Abdominal Aortic Aneurysms (INAA), Inflammatory aortic aneurysms (IAA) |
Primary outcome
Primary Graft Patency
Time frame: up to 36 months
Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Bowel Ischemia
Time frame: 30 days
Bowel Ischemia requiring surgical resection/not resolving with medical therapy. Outcome measures include the number of Participants with bowel ischemia after surgery.
Presence of aortic aneurysm endoleak after surgery
Time frame: up to 30 days
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.
Aneurysm-related mortality (ARM)
Time frame: up to 30 days
Outcome measures include the number of participants who died 30 days after the procedure.
Conversion to Open Surgical Repair (OSR)
Time frame: up to 30 days
Outcome measures include the number of participants whose cases converted from endovascular aortic aneurysm repair to open surgical repair.
Aortic rupture
Time frame: up to 30 days.
Outcome measures include the number of participants who had aortic rupture.
Post-operative infection-related complication (IRC)
Time frame: up to 24 months
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.
The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies.
Time frame: up to 36 months
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
3 secondary outcomes
Assessment of Adverse Events (AEs) described in the protocol.
Time frame: up to 36 months
All Cause Mortality
Time frame: 24 months
Continued Aortic sac growth.
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- CEVARII research project sign up link for interested sites.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEL J Sharafuddin, MD principal investigator
Memorial Hospital Central, University of Colorado Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Abdominal Aortic Aneurysm and Aneurysm, Infected, run by CEVARII at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Graft Patency (time frame: up to 36 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.