Greek Study for Endovascular Repair of Ruptured Abdominal Aortic Aneuryms

NCT ID: NCT04471181

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Rupture, Aortic; Aneurysm, Abdominal Aortic; Aneurysm, Ruptured

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients with ruptured abdominal aortic aneurysms

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.

Endovascular repair of ruptured abdominal aortic aneurysm (EVAR) with Medtronic Endurant

Intervention Type: DEVICE

Endovascular repair (EVAR) of ruptured abdominal aortic aneurysms with Medtronic Endurant II, and IIs device

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 :

• Neck diameter >17mm, < 32mm
• Angle between the suprarenal aorta and the juxtarenal aorta <60 degrees
• Angle between the juxtarenal aorta and the long axis of the aneurysm sac <90 degrees
• Neck length >10mm
• Neck length <10mm down to 4mm with Heli-FX EndoAnchor system
• Adequate aortic bifurcation diameter in case of a bifurcated graft
• Bilateral Iliac luminal diameter >7mm

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

• Symptomatic non ruptured AAAs will not be included even when treated as emergencies. Thoracoabdominal aneurysms and aortic dissections will also be excluded from the research study. Juxtarenal ruptured AAA treated with standard EVAR without chimney technique, outside IFU will also be excluded from the research study.However all consecutive rAAAs in the participating centers will be collected in a screening CRF to understand if this relates to rEVAR applicability.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: collaborator

Kostantinos Papazoglou

OTHER

Sponsor Role: lead

Responsible Party

Kostantinos Papazoglou

Professor in Vascular surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kostantinos Papazoglou, Professor

Role: PRINCIPAL_INVESTIGATOR

Aristotle University Of Thessaloniki

Locations

Ippokrateio General Hospital

Thessaloniki, Macedonia, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Kostantinos Papazoglou, Professor

Role: CONTACT

kpapas@auth.gr

00306944582211

Ioakeim Giagtzidis, Consultant

Role: CONTACT

kimisnet@gmail.com

00306979666129

Facility Contacts

Konstantinos Papazoglou, Prof

Role: primary

kpapas@auth.gr

00306944582211

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Other Identifiers

GRAND study

Identifier Type: -

Identifier Source: org_study_id