Abdominal Aortic AneurysmNCT03763812
Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)
A study testing Endovascular Aneurysm Repair (EVAR) and Endovascular Aneurysm Sealing (EVAS) in people with Abdominal Aortic Aneurysm and Inflammatory Response, run by Rijnstate Hospital at 7 sites in 5 countries.
Trial summary
Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Inflammatory Response
- What is being tested?
- Endovascular Aneurysm Repair (EVAR) and Endovascular Aneurysm Sealing (EVAS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Dec 2019to Dec 2021
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective EVAR/EVAS
- Ability and willingness to provide written informed consent
- Age >50 years
Who cannot join
- Complex EVAR or EVAS, including iliac branched and supra-renal repairs (pre-planned visceral chimneys, fenestrations or branches)
- Ruptured or symptomatic AAA
- Planned internal iliac artery embolization
- Acute or chronic inflammatory illness (i.e. upper respiratory tract infection)
- Active rheumatoid arthritis
- Inflammatory bowel disease, etc.)
Show all 12Show fewer
- Inflammatory and mycotic aneurysms
- Planned associated surgical procedure (i.e. iliac conduit, femoral endarterectomy, etc.)
- Previous aortic surgery (open or endovascular)
- Untreated malignancy
- Major surgery six weeks before EVAR/EVAS
- Ongoing or recent immunosuppressive treatment, including corticosteroid use
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Poland3 sites
University Hospital No.1
Bydgoszcz
Szpital Wojewódzki nr 4
Bytom
Institution Hematologii I Transfuzjologii,
Warsaw
About this study
Official title: Explorative Study on the Inflammatory Response After Endovascular Aortic Aneurysm Repair and Endovascular Aneurysm Sealing.
Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage.
This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration.
Read more
Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery.
Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.
Read the detailed description
Endovascular sealing of abdominal aortic aneurysms (EVAS) is a new technique to treat infrarenal abdominal aortic aneurysms (AAA), which can be performed more expeditiously than endovascular aneurysm repair (EVAR). The difference with EVAR is that fixation and seal are provided from polymer filled endobags that are placed in the aneurysmal sac. The post-implantation syndrome (PIS) is the clinical and biochemical expression of an inflammatory response following endovascular repair of an aortic aneurysm. More specifically, the presence of fever (body temperature >38 C for ≥1 day) and leukocytosis (white blood cell count (WBC) >12.000/mL) with negative blood cultures and is occurring in over 30% cases after EVAR. It is related to prolonged hospital stay and elevated CRP levels, that in turn increase the risk on major adverse cardiac events. The literature showed that the magnitude of the post-operative inflammatory response depends on the type of endoprothesis used for EVAR and that EVAS is related to a lower post-operative CRP level, lower white blood counts, a lower temperature and less cardiac complications compared to standard EVAR.
The current study was designed to explore the occurence of the post-implant syndrome after EVAR and EVAS. This study was also designed to unravel the cytokines which are involved in the post-implant syndrome after EVAR and EVAS.
In this international, prospective, explorative study 60 patients who are scheduled for EVAR and 60 patients who are scheduled for EVAS will be included. Blood samples (for WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP)) will be taken at:
- Before induction of anesthesia
- At wound closure
- 24 hours after surgery
- 48 hours after surgery
- 1 month after surgery
- 6 months after surgery
- 12 months after surgery
Patients are finished with the study after 12 months of follow-up.
- Conditions
- Abdominal Aortic Aneurysm, Inflammatory Response
- Being tested
- Endovascular Aneurysm Repair (EVAR), Endovascular Aneurysm Sealing (EVAS)
- Keywords
- EVAR, EVAS, Post implant syndrome, Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aneurysm Repair (EVAR)Procedure or surgery
The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points:
- Before induction of anesthesia
- At wound closure
- 24 hours after surgery
- 48 hours after surgery
- 1 month after surgery
- 6 months after surgery
- 12 months after surgery
Endovascular Aneurysm Sealing (EVAS)Procedure or surgery
The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points:
- Before induction of anesthesia
- At wound closure
- 24 hours after surgery
- 48 hours after surgery
- 1 month after surgery
- 6 months after surgery
- 12 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Aneurysm Repair (EVAR) | Other | Patients scheduled for EVAR will be included and blood samples at 7 time points will be taken. Receives: Procedure: Endovascular Aneurysm Repair (EVAR) |
| Endovascular Aneurysm Sealing (EVAS) | Other | Patients scheduled for EVAS will be included and blood samples at 7 time points will be taken. Receives: Procedure: Endovascular Aneurysm Sealing (EVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory response between EVAS and EVAR
The change in early post-operative inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
Measured: Up to 12 months after surgery.
Change in inflammatory response between EVAS and EVAR
The change in long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
Measured: Up to 12 months after surgery.
Secondary outcomes (6)
Change in aortic thrombus volume
The change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.
Measured: Up to 12 months after surgery.
Pyrexia post operative
Post-operative pyrexia, measured at 24 and 48 hours.
Measured: 24 to 48 hours after surgery
30-day Morbidity
30-day morbidity measured by cytokines' concentrations.
Measured: Up to 30 days after surgery
1 year morbidity
1 year morbidity measured by cytokines' concentrations.
Measured: Up to 12 months after surgery.
Cardiac complications
Cardiac complications (including measures of Troponin T, hsTnT, NT-proBNP) measured by cytokines' concentrations.
Measured: Up to 12 months after surgery.
Mortality
(all-cause and cardiac) mortality measured by cytokines' concentrations.
Measured: Up to 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Nellix stent cannot be placed in patients yet.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763812
- Sponsor's protocol ID
- INSPIRE study
- Status last verified
- Mar 2019
- First submitted
- 13 Nov 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Study on the Inflammatory Response After Endovascular Aortic Aneurysm Repair and Endovascular Aneurysm Sealing.
- ClinicalTrials.gov ID
- NCT03763812
- Acronym / sponsor ID
- INSPIRE study
- Conditions
- Abdominal Aortic Aneurysm, Inflammatory Response
- Keywords
- EVAR, EVAS, Post implant syndrome, Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Nellix stent cannot be placed in patients yet.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Dec 2018 (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.
Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage.
This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration.
Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery.
Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.
Detailed description
Endovascular sealing of abdominal aortic aneurysms (EVAS) is a new technique to treat infrarenal abdominal aortic aneurysms (AAA), which can be performed more expeditiously than endovascular aneurysm repair (EVAR). The difference with EVAR is that fixation and seal are provided from polymer filled endobags that are placed in the aneurysmal sac. The post-implantation syndrome (PIS) is the clinical and biochemical expression of an inflammatory response following endovascular repair of an aortic aneurysm. More specifically, the presence of fever (body temperature >38 C for ≥1 day) and leukocytosis (white blood cell count (WBC) >12.000/mL) with negative blood cultures and is occurring in over 30% cases after EVAR. It is related to prolonged hospital stay and elevated CRP levels, that in turn increase the risk on major adverse cardiac events. The literature showed that the magnitude of the post-operative inflammatory response depends on the type of endoprothesis used for EVAR and that EVAS is related to a lower post-operative CRP level, lower white blood counts, a lower temperature and less cardiac complications compared to standard EVAR.
The current study was designed to explore the occurence of the post-implant syndrome after EVAR and EVAS. This study was also designed to unravel the cytokines which are involved in the post-implant syndrome after EVAR and EVAS.
In this international, prospective, explorative study 60 patients who are scheduled for EVAR and 60 patients who are scheduled for EVAS will be included. Blood samples (for WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP)) will be taken at:
- Before induction of anesthesia
- At wound closure
- 24 hours after surgery
- 48 hours after surgery
- 1 month after surgery
- 6 months after surgery
- 12 months after surgery
Patients are finished with the study after 12 months of follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Aneurysm Repair (EVAR) | Other | Procedure: Endovascular Aneurysm Repair (EVAR)Patients scheduled for EVAR will be included and blood samples at 7 time points will be taken. |
| Endovascular Aneurysm Sealing (EVAS) | Other | Procedure: Endovascular Aneurysm Sealing (EVAS)Patients scheduled for EVAS will be included and blood samples at 7 time points will be taken. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective EVAR/EVAS
- Ability and willingness to provide written informed consent
- Age >50 years
Key exclusion criteria (12 listed)
- Complex EVAR or EVAS, including iliac branched and supra-renal repairs (pre-planned visceral chimneys, fenestrations or branches)
- Ruptured or symptomatic AAA
- Planned internal iliac artery embolization
- Acute or chronic inflammatory illness (i.e. upper respiratory tract infection)
- Active rheumatoid arthritis
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 |
|---|---|---|
| Endovascular Aneurysm Repair (EVAR)The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points: * Before induction of anesthesia * At wound closure * 24 hours after surgery * 48 hours after surgery * 1 month after surgery * 6 months after surgery * 12 months after surgery | Procedure or surgery | Endovascular Aneurysm Repair (EVAR) |
| Endovascular Aneurysm Sealing (EVAS)The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points: * Before induction of anesthesia * At wound closure * 24 hours after surgery * 48 hours after surgery * 1 month after surgery * 6 months after surgery * 12 months after surgery | Procedure or surgery | Endovascular Aneurysm Sealing (EVAS) |
Primary outcome
Change in inflammatory response between EVAS and EVAR
Time frame: Up to 12 months after surgery.
The change in early post-operative inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
Change in inflammatory response between EVAS and EVAR
Time frame: Up to 12 months after surgery.
The change in long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome.
6 secondary outcomes
Change in aortic thrombus volume
Time frame: Up to 12 months after surgery.
Pyrexia post operative
Time frame: 24 to 48 hours after surgery
30-day Morbidity
Time frame: Up to 30 days after surgery
1 year morbidity
Time frame: Up to 12 months after surgery.
Cardiac complications
Time frame: Up to 12 months after surgery.
Mortality
Time frame: Up to 12 months after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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.
Michel Reijnen principal investigator
Rijnstate Hospital
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Aneurysm Repair (EVAR) and Endovascular Aneurysm Sealing (EVAS) in people with Abdominal Aortic Aneurysm and Inflammatory Response, run by Rijnstate Hospital at 7 sites in 5 countries.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Germany, Netherlands, New Zealand, Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in inflammatory response between EVAS and EVAR (time frame: Up to 12 months after surgery.). The study lists 2 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 29 Mar 2019.