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

Aortic Aneurysms Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168037
• Other study ID #: IC090126
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: October 18, 2017
• Start date: June 17, 2009
• Est. completion date: February 9, 2015

Study information

• Verified date: October 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 9, 2015
• Est. primary completion date: February 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysms

Intervention

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

Procedure:
• Open Surgical Repair
aortic replacement with revascularization of visceral arteries

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Epub 2006 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day postoperative mortality		30-day postoperative
Secondary	complications		30-day postoperative
Secondary	Length of Intensive Care Unit (ICU) stay		30-day postoperative
Secondary	Length of Hospital stay		30-day postoperative
Secondary	Overall cost		30-day postoperative
Secondary	Reinterventions		2-year follow up
Secondary	Global survival		2-year follow up
Secondary	Mortality in touch with aneurysm		2-year follow up
Secondary	Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )		2-year follow up