NCT00583050

Brief Summary

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,366

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2001

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 8, 2020

Completed
Last Updated

May 8, 2020

Status Verified

April 1, 2020

Enrollment Period

18.9 years

First QC Date

December 20, 2007

Results QC Date

March 3, 2020

Last Update Submit

April 29, 2020

Conditions

Thoracoabdominal AneurysmAbdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Freedom From Aneurysm Rupture

    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

    2 years

Study Arms (1)

Endovascular Aneurysm Repair

EXPERIMENTAL

Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts

Device: Endovascular Aneurysm Repair

Interventions

Endovascular Aneurysm RepairDEVICE

Endovascular exclusion of aneurysm

Also known as: Cook Zenith
Endovascular Aneurysm Repair

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age.
  • Not pregnant
  • Willing and able to comply with two-year follow-up period.
  • Willing and able to give informed consent prior to enrollment
  • No known allergy to stainless steel or polyester
  • No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
  • Life expectancy greater than two years
  • High risk candidate for open surgical repair

You may not qualify if:

  • see above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (13)

  • Zhang J, Brier C, Parodi FE, Kuramochi Y, Lyden SP, Eagleton MJ. Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 Oct;72(4):1360-1366. doi: 10.1016/j.jvs.2019.12.040. Epub 2020 Mar 12.

    PMID: 32173192DERIVED

  • Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.

    PMID: 26792544DERIVED

  • Sylvan J, Brier C, Wolski K, Yanof J, Goel V, Kuramochi Y, Eagleton MJ. Impact of alterations in target vessel curvature on branch durability after endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Mar;63(3):634-41. doi: 10.1016/j.jvs.2015.09.053. Epub 2015 Nov 29.

    PMID: 26620715DERIVED

  • Mastracci TM, Eagleton MJ, Kuramochi Y, Bathurst S, Wolski K. Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms. J Vasc Surg. 2015 Feb;61(2):355-64. doi: 10.1016/j.jvs.2014.09.068.

    PMID: 25619574DERIVED

  • O'Callaghan A, Greenberg RK, Eagleton MJ, Bena J, Mastracci TM. Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality. J Vasc Surg. 2015 Apr;61(4):908-14. doi: 10.1016/j.jvs.2014.10.085. Epub 2015 Jan 16.

    PMID: 25600335DERIVED

  • O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia. J Vasc Surg. 2015 Feb;61(2):347-354.e1. doi: 10.1016/j.jvs.2014.09.011. Epub 2014 Oct 23.

    PMID: 25449006DERIVED

  • O'Callaghan A, Mastracci TM, Greenberg RK, Eagleton MJ, Bena J, Kuramochi Y. Outcomes for supra-aortic branch vessel stenting in the treatment of thoracic aortic disease. J Vasc Surg. 2014 Oct;60(4):914-20. doi: 10.1016/j.jvs.2013.12.053. Epub 2014 Jul 1.

    PMID: 24993951DERIVED

  • Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1.

    PMID: 24188715DERIVED

  • Mohapatra A, Greenberg RK, Mastracci TM, Eagleton MJ, Thornsberry B. Radiation exposure to operating room personnel and patients during endovascular procedures. J Vasc Surg. 2013 Sep;58(3):702-9. doi: 10.1016/j.jvs.2013.02.032. Epub 2013 Jun 28.

    PMID: 23810300DERIVED

  • Brown CR, Greenberg RK, Wong S, Eagleton M, Mastracci T, Hernandez AV, Rigelsky CM, Moran R. Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives. J Vasc Surg. 2013 Sep;58(3):573-81. doi: 10.1016/j.jvs.2013.02.239. Epub 2013 Jul 1.

    PMID: 23809203DERIVED

  • Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM, Roselli EE. Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms. J Vasc Surg. 2013 Sep;58(3):625-34. doi: 10.1016/j.jvs.2013.01.049. Epub 2013 Jun 22.

    PMID: 23800455DERIVED

  • Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.

    PMID: 23611709DERIVED

  • Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in branched and fenestrated endografts. J Vasc Surg. 2013 Apr;57(4):926-33; discussion 933. doi: 10.1016/j.jvs.2012.09.071. Epub 2013 Feb 20.

    PMID: 23433817DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Matthew Eagleton, M. D.
Organization
Massachusetts General Hospital
MEAGLETON@mgh.harvard.edu
617-726-8279

Study Officials

  • Behzad Farivar, M. D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

February 1, 2001

Primary Completion

December 31, 2019

Study Completion

February 1, 2020

Last Updated

May 8, 2020

Results First Posted

May 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)