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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014