An observational study in Rupture, Aortic, Aneurysm, Abdominal Aortic and Aneurysm, Ruptured, sponsored by Kostantinos Papazoglou. Status unknown at 1 site in Greece. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Kostantinos Papazoglou · Observational
This will be a non-randomized, prospective, observational multi-center research study. Its purpose will be to assess the mortality and outcome of EVAR in patients with rAAA. As mentioned in the introduction, EVAR approach for ruptured bdominal aortic aneurysms is nowdays common clinical practice in many vascular centers , and the main treatment option in Hippokrateio General hospital. The same applies in all future participating vascular centers.
Ruptured abdominal aortic aneurysms (rAAAs) remain one of the most emergent medical events, with over 90% mortality if left untreated and a prevalence of a minimum 45 patients per 1000000 population. The 30 day mortality for emergency open repair has remained at around 50%, and there is no consistent improvement in the outcome of the open technique over time. Since its development, endovascular aneurysm repair (EVAR), has been increasingly used even in the emergency setting.
So far there have been 4 randomized controlled trials, comparing EVAR versus open repair for rAAA. The first was a small trial from Nottingham followed by the Dutch trial AJAX and the French ECAR. The last and biggest trial with 613 patients was the UK IMPROVE trial. All these trials showed non inferiority of EVAR, but failed to prove benefit for EVAR with respect to 30 day mortality. Furthermore two meta-analysisof the above RCTs, stated again, that 30 and 90 day mortality is similar between EVAR and open surgery, with the exception of women having a better outcome with an endovascular approach.
On the contrary, multiple observational studies and registries showed even a 50% risk reduction in mortality with EVAR. There has been huge critique and discussion of the results in IMPROVE trial, in which 10% of patients crossed over to the non-allocated treatment group. In both groups, patients who were treated with EVAR had a mortality of 25%, significantly lower than those who received open surgery (38%). Furthermore, two recent published studies that compared mortality of rAAA between Sweden, USA and UK, came to the conclusion that mortality is lower in centers that accept a large number of cases with rAAA, mostly treated with EVAR. There is an argument that these encouraging results are subject of bias, since there is patient selection according to haemodynamic stability and aortic morphology. A valid counter argument stated by Lachat and colleagues is that EVAR for rAAA in their center, in the moderate risk, stable patient with favourable anatomy (aortic neck length >10mm) has a reduced 30 day mortality of 10%, a result never demonstrated with open repair. As EVAR evolves, new technical features of the devices may address the current limitations of the technique. In addition, the anatomic suitability obstacle for EVAR has been revoked by the PROTAGORAS study, which led to CE mark for a commercial stent graft system, allowing treatment of aortic neck lengths as small as 2mm with the use of chimney technique. The authors in the IMPROVE trial acknowledge the fact that: "The suitability of ruptured aneurym for EVAR is subjective and will be defined by the aortic morphology, the experience of the operator and the range of resuscitation, endovascular and anaesthetic techniques available".
It is safe to guess that haemodynamically compromised patients would benefit from a less invasive procedure, with minimum surgical exposure, if any, and local anaesthesia. There is no doubt however that for a center to adopt an EVAR only policy, poses many logistical challenges.
The aim for this research study is that an "EVAR first" approach is feasible in rAAA, even in more complex anatomies and in patients with less physiologic reserve and at the same time prove that short and midterm mortality and morbidity with EVAR is significantly lower than open repair when compared to the mortality and morbidity rates of patients receiving open repair in the latest RCT "IMPROVE". This can be achieved, with implementing a treatment alogorithm for the pre intra and post operative time, based on already established protocols and relevant international standards, with single aim to avoid the factors in patient management that contribute to mortality and morbidity. Furthermore this research study will show increased applicability of EVAR in ruptured AAAs with shorter and larger in diameter proximal neck and with angulation >60 degrees, with the implementation of EndoAnchors (HeliFX). Another aim for this research study is to identify the role of the clotting mechanism in the overall mortality and thus to distinguish patient clotting profiles that can predict or alter the outcome.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 157 is close to the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →This is the only study on the registry with Kostantinos Papazoglou as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All consecutive alive patients with true ruptured abdominal aortic aneurysm and anatomic suitability for EVAR
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All alive patients admitted with rAAA and have anatomic suitability for EVAR according to manufacturer's IFU. More accurately the anatomic criteria for the research study are :
The vascular surgeon in charge will make the ultimate decision on suitability. All consecutive rAAAs treated with Endurant will be collected to avoid selection bias. No other criteria (e.g, mental illness, dementia, old age, comorbidities) will be applied to decline treatment and inclusion to the protocol. The final inclusion criterion will be that any vascular surgeon participating in the research study, must have carried out a minimum of 20 EVAR procedures for asymptomatic/symptomatic AAA. Apart from the initial 6 centers more centers can be implemented in the research study in the future.
AAA rupture will be confirmed and defined with computed tomography angiography (CTA). Rupture will be rated as free intraperitoneal rupture (free rupture), definite contrast extravasation and haematoma around the aorta (retroperitoneal rupture) and haematoma surrounding the aorta without definite contrast leak (contained rupture)
Exclusion Criteria:
All patients will undergo CTA to confirm the diagnosis. The use of balloon for aortic clamp in case of haemodynamic instability can be used. All patients included in the research study must undergo standard EVAR with a bifurcated graft or an aorto-uni-iliac and a femoral to femoral crossover. In aneurysms with short proximal neck down to 4mm, or in cases where completion angiography indicates type Ia endoleak, the Heli-FX EndoAnchor system is recommended to be used, as indicated. All patients will have plain abdominal x-rays on discharge. Participants will undergo CTA in 3months and annually post-op.. In case of an adverse event before the 3 months follow up CTA, a more urgent imaging might be requested and proceed to appropriate action according to the findings.
Device: Endovascular repair of ruptured abdominal aortic aneurysm (EVAR) with Medtronic Endurant
Endovascular repair (EVAR) of ruptured abdominal aortic aneurysms with Medtronic Endurant II, and IIs device
Mortality Rate
Any cause mortality after EVAR
Time frame: 30 days
Time from rupture to diagnosis
In minutes
Time frame: pre-intervention
Time from diagnosis to intervention
In minutes
Time frame: pre-intervention
Rate of procedures converted to open repair
Any reason for conversion to open repair
Time frame: 24 hours post-operatively
Total mortality rate
All cause mortality
Time frame: 12 months post-operatively
Rate of Major Adverse Events (MAE)
MAE include :bowel ischaemia, myocardial infraction, paraplegia, renal failure, stroke, abdominal compartment syndrome, lower limb ischeamia
Time frame: 30 days, 3 months and 12 months
Rate of Endoleaks
Any endoleak observed
Time frame: immediately after the procedure, 3 months after the procedure, 12 months after the procedure
Rate of Graft related complications
Any graft related complication
Time frame: 12 months after the procedure
Fibrinogel levels
Fibrinogen levels mg/dL
Time frame: Pre-intervention, 24 hours after the procedure, 3 months after the procedure,12 months after the procedure
Plan to share: Yes — All IPD data that underlie results in a publication will be released by the end of the study
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: By the end of the study, until publication
Access criteria: GDPR compatible
Started Feb 2020 (actual). Primary completion is estimated for Feb 2022, 24 months after the start.
Of 67 non-industry observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 24 months is below that.
Counting every sponsor, half of 91 studies reached it within 48 months; a quarter within 24 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.