Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms (Windows1)

Medical and Economical Evaluation of Endovascular Therapy of Complex Aortic Aneurysms (Para- & Supra- Renal Abdominal Aortic Aneurysms, Type 4 THORACO-Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts

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).

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysms
• Intervention / Treatment: Procedure: Open Surgical Repair; Device: Endovascular aortic repair with branched/fenestrated stent-graft

Detailed Description

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).

In-hospital morbidity are similarly expected to be lower in the endovascular group. We also wish to demonstrate that endovascular repair does not represent a significant over-cost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

The following anatomical inclusion criteria must be met:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open repair; Open Surgical Repair (aortic replacement with revascularization of visceral arteries)	Procedure: Open Surgical Repair; aortic replacement with revascularization of visceral arteries
Endovascular (Windows 1); Endovascular therapy branched or fenestrated stent-graft	Device: Endovascular aortic repair with branched/fenestrated stent-graft; Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram; Other Names: Endovascular aortic repair
Endovascular (Windows 3); Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda)	Device: Endovascular aortic repair with branched/fenestrated stent-graft; Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram; Other Names: Endovascular aortic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day postoperative mortality	30-day postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Global survival	2-year follow up
Mortality in touch with aneurysm	2-year follow up
Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )	2-year follow up

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jean-Pierre Becquemin, PU-PH, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2009
• Primary Completion (Actual): February 9, 2015
• Study Completion (Actual): February 9, 2015

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: endovascular; Aneurysm; Aorta; stent-graft
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: IC090126