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

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ClinicalTrials.gov Identifier: NCT01168037
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date July 21, 2010
First Posted Date July 22, 2010
Last Update Posted Date October 19, 2017
Actual Study Start Date June 17, 2009
Actual Primary Completion Date February 9, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2010)
30-day postoperative mortality [ Time Frame: 30-day postoperative ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 21, 2010)
  • complications [ Time Frame: 30-day postoperative ]
  • Length of Intensive Care Unit (ICU) stay [ Time Frame: 30-day postoperative ]
  • Length of Hospital stay [ Time Frame: 30-day postoperative ]
  • Overall cost [ Time Frame: 30-day postoperative ]
  • Reinterventions [ Time Frame: 2-year follow up ]
  • Global survival [ Time Frame: 2-year follow up ]
  • Mortality in touch with aneurysm [ Time Frame: 2-year follow up ]
  • Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening ) [ Time Frame: 2-year follow up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms
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
Brief Summary

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).

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 (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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Aortic Aneurysms
Intervention
  • 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
Study Groups/Cohorts
  • Open repair
    Open Surgical Repair (aortic replacement with revascularization of visceral arteries)
    Intervention: Procedure: Open Surgical Repair
  • Endovascular (Windows 1)
    Endovascular therapy branched or fenestrated stent-graft
    Intervention: Device: Endovascular aortic repair with branched/fenestrated stent-graft
  • Endovascular (Windows 3)
    Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda)
    Intervention: Device: Endovascular aortic repair with branched/fenestrated stent-graft
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 18, 2017)
270
Original Estimated Enrollment
 (submitted: July 21, 2010)
220
Actual Study Completion Date February 9, 2015
Actual Primary Completion Date February 9, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01168037
Other Study ID Numbers IC090126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Pierre Becquemin, PU-PH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2017