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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01168037
First received: July 21, 2010
Last updated: November 7, 2013
Last verified: November 2013

July 21, 2010
November 7, 2013
June 2009
July 2013   (final data collection date for primary outcome measure)
30-day postoperative mortality [ Time Frame: 30-day postoperative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01168037 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 ]
  • Mortality in touch with aneurysm [ Time Frame: 2-year follow up ] [ Designated as safety issue: Yes ]
  • Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening ) [ 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 Aortic Aneurysms
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).

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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
Aortic Aneurysms
  • 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 Name: Endovascular aortic repair
  • Procedure: Open Surgical Repair
    aortic replacement with revascularization of visceral arteries
    Other Name: Open Surgical Repair
  • Open repair
    Open Surgical Repair (aortic replacement with revascularization of visceral arteries)
    Intervention: Procedure: Open Surgical Repair
  • Endovascular
    Endovascular therapy branched or fenestrated stent-graft
    Intervention: Device: Endovascular aortic repair with branched/fenestrated stent-graft

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
June 2015
July 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 information is only displayed when the study is recruiting subjects
France
 
NCT01168037
IC090126
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