Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms

NCT01168037 | Completed DMC

• 1 other identifier: IC090126
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms. The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).

Conditions

Aortic Aneurysms

Keywords

Aorta; Aneurysm; endovascular; stent-graft

Outcome Measures

Primary Outcomes (1)

• 30-day postoperative mortality

  30-day postoperative

Secondary Outcomes (8)

• complications

  30-day postoperative

• Length of Intensive Care Unit (ICU) stay

  30-day postoperative

• Length of Hospital stay

  30-day postoperative

• Overall cost

  30-day postoperative

• Reinterventions

  2-year follow up

Study Arms (3)

Open repair

Open Surgical Repair (aortic replacement with revascularization of visceral arteries)

Procedure: Open Surgical Repair

Endovascular (Windows 1)

Endovascular therapy branched or fenestrated stent-graft

Device: Endovascular aortic repair with branched/fenestrated stent-graft

Endovascular (Windows 3)

Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda)

Device: Endovascular aortic repair with branched/fenestrated stent-graft

Interventions

Endovascular aortic repair with branched/fenestrated stent-graft DEVICE

Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram

Also known as: Endovascular aortic repair

Endovascular (Windows 1); Endovascular (Windows 3)

Open Surgical Repair PROCEDURE

aortic replacement with revascularization of visceral arteries

Open repair

Eligibility Criteria

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

Study Population

All patients with an Abdominal aortic aneurysm over 5 cm in diameter or with a diameter increase over 1 cm in 1 year and a PSRAA defined by: * Infrarenal aortic neck \< 15 mm * or extent of the aneurismal process to the suprarenal aorta

You may qualify if:

• Absence of significant angulations (\< 60°) of aorta or of iliac arteries
• Absence of tight stenosis (\>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
• Diameter of target arteries over 5 mm
• Iliac and femoral arteries allowing insertion of the delivery system (\> 7 mm) or suitable for insertion of an access conduit

You may not qualify if:

• Limited expected life expectancy
• Emergency cases
• Refuse to participate to the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (4)

• O'Neill S, Greenberg RK, Haddad F, Resch T, Sereika J, Katz E. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-23. doi: 10.1016/j.ejvs.2006.01.015. Epub 2006 Mar 31.

  PMID: 16580236 BACKGROUND

• Michel M, Becquemin JP, Clement MC, Marzelle J, Quelen C, Durand-Zaleski I; WINDOW Trial Participants. Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):189-96. doi: 10.1016/j.ejvs.2015.04.012. Epub 2015 Jun 19.

  PMID: 26100447 DERIVED

• Marzelle J, Presles E, Becquemin JP; WINDOWS trial participants. Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study. Ann Surg. 2015 Jan;261(1):197-206. doi: 10.1097/SLA.0000000000000612.

  PMID: 24670864 DERIVED

• Banno H, Kobeiter H, Brossier J, Marzelle J, Presles E, Becquemin JP. Inter-observer variability in sizing fenestrated and/or branched aortic stent-grafts. Eur J Vasc Endovasc Surg. 2014 Jan;47(1):45-52. doi: 10.1016/j.ejvs.2013.10.008. Epub 2013 Oct 23.

  PMID: 24268517 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm; Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Jean-Pierre Becquemin, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: June 17, 2009
• Primary Completion: February 9, 2015
• Study Completion: February 9, 2015
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

FR (1)