Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal Aneurysms (Windows2)

This study is currently recruiting participants.
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01354821
First received: May 16, 2011
Last updated: November 7, 2013
Last verified: November 2013

May 16, 2011
November 7, 2013
November 2009
December 2013   (final data collection date for primary outcome measure)
mortality [ Time Frame: 30-day postoperative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01354821 on ClinicalTrials.gov Archive Site
  • complications [ Time Frame: 30-day postoperative ] [ Designated as safety issue: No ]
  • Length of Intensive Care Unit (ICU) stay [ Time Frame: 30-day postoperative ] [ Designated as safety issue: No ]
  • Length of Hospital stay [ Time Frame: 30-day postoperative ] [ Designated as safety issue: No ]
  • Overall cost [ Time Frame: 30-day postoperative ] [ Designated as safety issue: No ]
  • Reinterventions [ Time Frame: 2-year follow up ] [ Designated as safety issue: No ]
  • Global survival [ Time Frame: 2-year follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal Aneurysms
Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal 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 type 1, 2 and 3 thoracal abdominal aortic aneurysms.

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal 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 (50 patients (amendment n.5 - 9/07/2013) treated in 5 University hospitals with significant experience of the technique) and open repair (220 similar patients analyzed from the national database of the MOH).

In-hospital morbidity are similarly expected to be lower in the endovascular group. The investigators also wish to demonstrate that endovascular repair does not represent a significant overcost, 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm
  • Procedure: Endovascular aortic repair
    Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
    Other Name: Endovascular aortic repair
  • Procedure: Open surgical repair
    Conventional therapy in France with the national database of the M.O.H.
    Other Name: Open surgical repair
  • Active Comparator: Endovascular therapy branched
    Endovascular therapy branched or fenestrated stent-graft
    Intervention: Procedure: Endovascular aortic repair
  • Open surgical repair
    Open surgical repair or aortic replacement with revascularization of visceral arteries
    Intervention: Procedure: Open surgical repair
Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P, Goueffic Y, Jean-Baptiste E, Cochennec F, Favre JP; Association Universitaire de Recherche en Chirurgie Vasculaire. Fenestrated endovascular grafting: the French multicentre experience. Eur J Vasc Endovasc Surg. 2010 May;39(5):537-44. doi: 10.1016/j.ejvs.2009.12.008. Epub 2010 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jean-Pierre Becquemin, PU-PH (0) 1 49 81 24 05 ext +33 jean-pierre.becquemin@hmn.aphp.fr
Contact: Dalila Selmane (0) 1 49 81 33 86 ext +33 dalila.selmane@hmn.aphp.fr
France
 
NCT01354821
P090209
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Jean-Pierre Becquemin, PU-PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP