NCT00583414

Brief Summary

The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1998

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

September 1, 1998

Completed
9.3 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
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

19.1 years

First QC Date

December 20, 2007

Results QC Date

November 30, 2018

Last Update Submit

January 21, 2019

Conditions

Abdominal Aortic AneurysmIliac AneurysmInternal Iliac 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

Investigational stent-graft implant to exclude aneurysm

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:

  • The aneurysm is \>/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (\>2 cm) iliac aneurysm
  • Anticipated mortality greater than 10 percent with conventional surgery
  • Life expectancy greater than 2 years
  • Suitable arterial anatomy
  • Absence of systemic disease or allergy that precludes an endovascular repair
  • Capable of giving informed consent and willingness to comply with the follow-up schedule

You may not qualify if:

  • Pregnancy
  • History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
  • Allergy to stainless steel or polyester
  • Unwilling to comply with the follow-up schedule
  • Serious or systemic groin infection
  • Coagulopathy, other than coumadin therapy
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

  • Farivar BS, Abbasi MN, Dias AP, Kuramochi Y, Brier CS, Parodi FE, Eagleton MJ. Durability of iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms. J Vasc Surg. 2017 Oct;66(4):1028-1036.e18. doi: 10.1016/j.jvs.2017.02.042. Epub 2017 May 11.

    PMID: 28502545DERIVED

  • 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

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalIliac Aneurysm

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, MD
Organization
Massachusetts General Hospital
meagleton@mgh.harvard.edu
617-726-8279

Study Officials

  • Matthew J Eagleton, MD

    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
Staff

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

September 1, 1998

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 25, 2019

Results First Posted

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)