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
  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 type 1, 2 and 3 thoracal abdominal aortic aneurysms.


Condition Intervention
Aortic Aneurysm
Procedure: Endovascular aortic repair
Procedure: Open surgical repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endovascular therapy branched
Endovascular therapy branched or fenestrated stent-graft
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
Open surgical repair
Open surgical repair or aortic replacement with revascularization of visceral arteries
Procedure: Open surgical repair
Conventional therapy in France with the national database of the M.O.H.
Other Name: Open surgical 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: NCT01354821

Contacts
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

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   
Contact: Dalila Selmane    (0)1 49 81 33 86 ext +33    dalila.selmane@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

Additional Information:
Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01354821     History of Changes
Other Study ID Numbers: P090209
Study First Received: May 16, 2011
Last Updated: November 7, 2013
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 April 17, 2014