Greek Study for Endovascular Repair of Ruptured Abdominal Aortic Aneuryms (GRAND)

August 25, 2021 updated by: Kostantinos Papazoglou

Greek Ruptured Aneurysm Endovascular Repair Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kostantinos Papazoglou, Professor
  • Phone Number: 00306944582211
  • Email: kpapas@auth.gr

Study Contact Backup

  • Name: Ioakeim Giagtzidis, Consultant
  • Phone Number: 00306979666129
  • Email: kimisnet@gmail.com

Study Locations

  • Greece
    • Macedonia
      • Thessaloníki, Macedonia, Greece, 54642
        • Recruiting
        • Ippokrateio General Hospital
        • Contact:
          • Konstantinos Papazoglou, Prof
          • Phone Number: 00306944582211
          • Email: kpapas@auth.gr
        • Sub-Investigator:
          • Christos Karkos, Ass Prof
        • Sub-Investigator:
          • Ioakeim Giagtzidis, Vasc Surg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive alive patients with true ruptured abdominal aortic aneurysm and anatomic suitability for EVAR

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: 30 days
Any cause mortality after EVAR
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from rupture to diagnosis
Time Frame: pre-intervention
In minutes
pre-intervention
Time from diagnosis to intervention
Time Frame: pre-intervention
In minutes
pre-intervention
Rate of procedures converted to open repair
Time Frame: 24 hours post-operatively
Any reason for conversion to open repair
24 hours post-operatively
Total mortality rate
Time Frame: 12 months post-operatively
All cause mortality
12 months post-operatively
Rate of Major Adverse Events (MAE)
Time Frame: 30 days, 3 months and 12 months
MAE include :bowel ischaemia, myocardial infraction, paraplegia, renal failure, stroke, abdominal compartment syndrome, lower limb ischeamia
30 days, 3 months and 12 months
Rate of Endoleaks
Time Frame: immediately after the procedure, 3 months after the procedure, 12 months after the procedure
Any endoleak observed
immediately after the procedure, 3 months after the procedure, 12 months after the procedure
Rate of Graft related complications
Time Frame: 12 months after the procedure
Any graft related complication
12 months after the procedure
Fibrinogel levels
Time Frame: Pre-intervention, 24 hours after the procedure, 3 months after the procedure,12 months after the procedure
Fibrinogen levels mg/dL
Pre-intervention, 24 hours after the procedure, 3 months after the procedure,12 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kostantinos Papazoglou

Collaborators

Aristotle University Of Thessaloniki
Medtronic

Investigators

  • Principal Investigator: Kostantinos Papazoglou, Professor, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

July 5, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAND study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD data that underlie results in a publication will be released by the end of the study

IPD Sharing Time Frame

By the end of the study, until publication

IPD Sharing Access Criteria

GDPR compatible

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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