Greek Study for Endovascular Repair of Ruptured Abdominal Aortic Aneuryms

NCT04471181 | Unknown FDA Device

• 1 other identifier: GRAND study
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ruptured Abdominal Aortic Aneurysm; Endovascular Repair

Outcome Measures

Primary Outcomes (1)

• Mortality Rate

  Any cause mortality after EVAR

  30 days

Secondary Outcomes (8)

• Time from rupture to diagnosis

  pre-intervention

• Time from diagnosis to intervention

  pre-intervention

• Rate of procedures converted to open repair

  24 hours post-operatively

• Total mortality rate

  12 months post-operatively

• Rate of Major Adverse Events (MAE)

  30 days, 3 months and 12 months

Study Arms (1)

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

Interventions

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

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

All patients with ruptured abdominal aortic aneurysms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kostantinos Papazoglou: lead
• Medtronic: collaborator
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

Ippokrateio General Hospital

Thessaloniki, Macedonia, 54642, Greece

RECRUITING

Related Publications (17)

• IMPROVE Trial Investigators; Powell JT, Sweeting MJ, Thompson MM, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve R, Heatley F, Hinchliffe RJ, Thompson SG, Ulug P. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial. BMJ. 2014 Jan 13;348:f7661. doi: 10.1136/bmj.f7661.

  PMID: 24418950 BACKGROUND

• Hinchliffe RJ, Bruijstens L, MacSweeney ST, Braithwaite BD. A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysm - results of a pilot study and lessons learned for future studies. Eur J Vasc Endovasc Surg. 2006 Nov;32(5):506-13; discussion 514-5. doi: 10.1016/j.ejvs.2006.05.016. Epub 2006 Aug 1.

  PMID: 16887369 BACKGROUND

• Reimerink JJ, Hoornweg LL, Vahl AC, Wisselink W, van den Broek TA, Legemate DA, Reekers JA, Balm R; Amsterdam Acute Aneurysm Trial Collaborators. Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial. Ann Surg. 2013 Aug;258(2):248-56. doi: 10.1097/SLA.0b013e31828d4b76.

  PMID: 23549424 BACKGROUND

• Desgranges P, Kobeiter H, Katsahian S, Bouffi M, Gouny P, Favre JP, Alsac JM, Sobocinski J, Julia P, Alimi Y, Steinmetz E, Haulon S, Alric P, Canaud L, Castier Y, Jean-Baptiste E, Hassen-Khodja R, Lermusiaux P, Feugier P, Destrieux-Garnier L, Charles-Nelson A, Marzelle J, Majewski M, Bourmaud A, Becquemin JP; ECAR Investigators. Editor's Choice - ECAR (Endovasculaire ou Chirurgie dans les Anevrysmes aorto-iliaques Rompus): A French Randomized Controlled Trial of Endovascular Versus Open Surgical Repair of Ruptured Aorto-iliac Aneurysms. Eur J Vasc Endovasc Surg. 2015 Sep;50(3):303-10. doi: 10.1016/j.ejvs.2015.03.028. Epub 2015 May 20.

  PMID: 26001320 BACKGROUND

• van Beek SC, Conijn AP, Koelemay MJ, Balm R. Editor's Choice - Endovascular aneurysm repair versus open repair for patients with a ruptured abdominal aortic aneurysm: a systematic review and meta-analysis of short-term survival. Eur J Vasc Endovasc Surg. 2014 Jun;47(6):593-602. doi: 10.1016/j.ejvs.2014.03.003. Epub 2014 Apr 18.

  PMID: 24746873 BACKGROUND

• Sweeting MJ, Balm R, Desgranges P, Ulug P, Powell JT; Ruptured Aneurysm Trialists. Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm. Br J Surg. 2015 Sep;102(10):1229-39. doi: 10.1002/bjs.9852. Epub 2015 Jun 24.

  PMID: 26104471 BACKGROUND

• Karthikesalingam A, Holt PJ, Vidal-Diez A, Ozdemir BA, Poloniecki JD, Hinchliffe RJ, Thompson MM. Mortality from ruptured abdominal aortic aneurysms: clinical lessons from a comparison of outcomes in England and the USA. Lancet. 2014 Mar 15;383(9921):963-9. doi: 10.1016/S0140-6736(14)60109-4.

  PMID: 24629298 BACKGROUND

• Karthikesalingam A, Wanhainen A, Holt PJ, Vidal-Diez A, Brownrigg JR, Shpitser I, Bjorck M, Thompson MM, Mani K. Comparison of long-term mortality after ruptured abdominal aortic aneurysm in England and Sweden. Br J Surg. 2016 Feb;103(3):199-206. doi: 10.1002/bjs.10049. Epub 2015 Dec 1.

  PMID: 26620854 BACKGROUND

• Vogel TR, Dombrovskiy VY, Haser PB, Graham AM. Has the implementation of EVAR for ruptured AAA improved outcomes? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):252-7. doi: 10.1177/1538574408329271. Epub 2009 Jan 8.

  PMID: 19131375 BACKGROUND

• Veith FJ, Lachat M, Mayer D, Malina M, Holst J, Mehta M, Verhoeven EL, Larzon T, Gennai S, Coppi G, Lipsitz EC, Gargiulo NJ, van der Vliet JA, Blankensteijn J, Buth J, Lee WA, Biasi G, Deleo G, Kasirajan K, Moore R, Soong CV, Cayne NS, Farber MA, Raithel D, Greenberg RK, van Sambeek MR, Brunkwall JS, Rockman CB, Hinchliffe RJ; RAAA Investigators. Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms. Ann Surg. 2009 Nov;250(5):818-24. doi: 10.1097/SLA.0b013e3181bdd7f5.

  PMID: 19809296 BACKGROUND

• Papazoglou K, Mallios A, Rafati F, Zambas N, Karkos C. Endovascular treatment of ruptured abdominal aortic aneurysms with the Endurant device. Ann Vasc Surg. 2013 Feb;27(2):162-7. doi: 10.1016/j.avsg.2012.04.013. Epub 2012 Sep 12.

  PMID: 22981014 BACKGROUND

• Donas KP, Torsello GB, Piccoli G, Pitoulias GA, Torsello GF, Bisdas T, Austermann M, Gasparini D. The PROTAGORAS study to evaluate the performance of the Endurant stent graft for patients with pararenal pathologic processes treated by the chimney/snorkel endovascular technique. J Vasc Surg. 2016 Jan;63(1):1-7. doi: 10.1016/j.jvs.2015.07.080. Epub 2015 Oct 23.

  PMID: 26476671 BACKGROUND

• Mayer D, Aeschbacher S, Pfammatter T, Veith FJ, Norgren L, Magnuson A, Rancic Z, Lachat M, Horer T, Skoog P, Larzon T. Complete replacement of open repair for ruptured abdominal aortic aneurysms by endovascular aneurysm repair: a two-center 14-year experience. Ann Surg. 2012 Nov;256(5):688-95; discussion 695-6. doi: 10.1097/SLA.0b013e318271cebd.

  PMID: 23095611 BACKGROUND

• Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, Matsumura JS, May J, Veith FJ, Fillinger MF, Rutherford RB, Kent KC; Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1048-60. doi: 10.1067/mva.2002.123763. No abstract available.

  PMID: 12021727 BACKGROUND

• Vu KN, Kaitoukov Y, Morin-Roy F, Kauffmann C, Giroux MF, Therasse E, Soulez G, Tang A. Rupture signs on computed tomography, treatment, and outcome of abdominal aortic aneurysms. Insights Imaging. 2014 Jun;5(3):281-93. doi: 10.1007/s13244-014-0327-3. Epub 2014 May 1.

  PMID: 24789068 BACKGROUND

• Mell MW, Starnes BW, Kraiss LW, Schneider PA, Pevec WC. Western Vascular Society guidelines for transfer of patients with ruptured abdominal aortic aneurysm. J Vasc Surg. 2017 Mar;65(3):603-608. doi: 10.1016/j.jvs.2016.10.097.

  PMID: 28236914 BACKGROUND

• Anjum A, von Allmen R, Greenhalgh R, Powell JT. Explaining the decrease in mortality from abdominal aortic aneurysm rupture. Br J Surg. 2012 May;99(5):637-45. doi: 10.1002/bjs.8698.

  PMID: 22473277 RESULT

MeSH Terms

Conditions

Aortic Rupture; Aortic Aneurysm, Abdominal; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases; Rupture; Wounds and Injuries

Study Officials

• Kostantinos Papazoglou, Professor

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kostantinos Papazoglou, Professor

CONTACT

00306944582211; kpapas@auth.gr

Ioakeim Giagtzidis, Consultant

CONTACT

00306979666129; kimisnet@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Vascular surgery

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 15, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: By the end of the study, until publication
• Access Criteria: GDPR compatible

Locations

GR (1)