NCT01354821

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 type 1, 2 and 3 thoracal abdominal aortic aneurysms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

4.2 years

First QC Date

May 16, 2011

Last Update Submit

October 29, 2014

Conditions

Aortic Aneurysm

Keywords

AortaAneurysmendovascularstent-graft

Outcome Measures

Primary Outcomes (1)

  • mortality

    30-day postoperative

Secondary Outcomes (6)

  • complications

    30-day postoperative

  • Length of Intensive Care Unit (ICU) stay

    30-day postoperative

  • Length of Hospital stay

    30-day postoperative

  • Overall cost

    30-day postoperative

  • Reinterventions

    2-year follow up

  • +1 more secondary outcomes

Study Arms (2)

Endovascular therapy branched

ACTIVE COMPARATOR

Endovascular therapy branched or fenestrated stent-graft

Procedure: Endovascular aortic repair

Open surgical repair

OTHER

Open surgical repair or aortic replacement with revascularization of visceral arteries

Procedure: Open surgical repair

Interventions

Endovascular aortic repairPROCEDURE

Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram

Endovascular therapy branched
Open surgical repairPROCEDURE

Conventional therapy in France with the national database of the M.O.H.

Open surgical repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Limited expected life expectancy
  • Emergency cases
  • Refuse to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (1)

  • Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P, Goueffic Y, Jean-Baptiste E, Cochennec F, Favre JP; Association Universitaire de Recherche en Chirurgie Vasculaire. Fenestrated endovascular grafting: the French multicentre experience. Eur J Vasc Endovasc Surg. 2010 May;39(5):537-44. doi: 10.1016/j.ejvs.2009.12.008. Epub 2010 Jan 25.

    PMID: 20093051BACKGROUND

MeSH Terms

Conditions

Aortic AneurysmAneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Jean-Pierre Becquemin, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

November 1, 2009

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

FR(1)