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

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01168037
First received: July 21, 2010
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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 (220 patients treated in 7University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).


Condition Intervention
Aortic Aneurysms
 Device: Endovascular aortic repair with branched/fenestrated stent-graft
Procedure: Open Surgical Repair

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 30-day postoperative mortality [ Time Frame: 30-day postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: November 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Open repair
Open Surgical Repair (aortic replacement with revascularization of visceral arteries)
 Procedure: Open Surgical Repair
aortic replacement with revascularization of visceral arteries
Other Name: Open Surgical Repair
Endovascular
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 Name: Endovascular aortic repair

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 (220 patients treated in 7University 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168037

Contacts
Contact: Jean-Pierre Becquemin, PU-PH (0) 1 49 81 24 05 ext +33 jean-pierre.becquemin@hmn.aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Jean-Pierre Becquemin, PU-PH     (0) 1 49 81 24 05 ext +33     jean-pierre.becquemin@hmn.aphp.fr    
Principal Investigator: Jean-Pierre Becquemin, PU-PH            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Pierre Becquemin, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01168037     History of Changes
Other Study ID Numbers: IC090126
Study First Received: July 21, 2010
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Aorta
Aneurysm
endovascular
stent-graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 19, 2013