NCT05607277

Brief Summary

This project seeks to determine if certain anatomic factors, specifically tortuous and non-conformable iliac arteries, may predict device complications, including seal zone failure, type III endoleak, and occlusion. Approximately 400 subjects from 5 academic centers across the United States, Europe, and Asia will be included in this study. Various markers of pre- and post-treatment iliac anatomy will be measured using CT imaging, and clinical events will be reported by academic centers. The relationship of imaging data to patient demographics will then be assessed alongside anatomic and demographic predictors of non-conformability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

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

November 1, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
Last Updated

April 19, 2024

Status Verified

October 1, 2022

Enrollment Period

6.1 years

First QC Date

October 26, 2022

Last Update Submit

April 18, 2024

Conditions

Abdominal Aortic AneurysmIliac Aneurysm

Keywords

Abdominal aortic aneurysmAorta-Iliac aneurysmEndovascular aneurysm repairIliac Branch Devices

Outcome Measures

Primary Outcomes (2)

  • Device conformability in relation to endovascular repair of abdominal aortoiliac aneurysms.

    Adverse events: any radiographic or clinical ipsilateral complication, i.e. dissection, kink, compression, occlusion, endoleaks.

    Pre-treatment

  • Device conformability in relation to endovascular repair of abdominal aortoiliac aneurysms.

    Adverse events: any radiographic or clinical ipsilateral complication, i.e. dissection, kink, compression, occlusion, endoleaks.

    1 day at First post-operative imaging appointment

Interventions

Endovascular Repair of abdominal aortic aneurysmsPROCEDURE

Femoral artery access

Also known as: Endovascular repair of abdominal aorto-iliac aneurysm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

400 subjects with Endovascular repair with Iliac Branched Devices for treatment of abdominal aortic aneurysm with iliac involvement.

You may qualify if:

  • Subjects who have undergone endovascular aortic repair of AAA with iliac involvement via iliac branch device.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (16)

  • Chichester Aneurysm Screening Group; Viborg Aneurysm Screening Study; Western Australian Abdominal Aortic Aneurysm Program; Multicentre Aneurysm Screening Study. A comparative study of the prevalence of abdominal aortic aneurysms in the United Kingdom, Denmark, and Australia. J Med Screen. 2001;8(1):46-50. doi: 10.1136/jms.8.1.46.

    PMID: 11373850BACKGROUND

  • Derubertis BG, Trocciola SM, Ryer EJ, Pieracci FM, McKinsey JF, Faries PL, Kent KC. Abdominal aortic aneurysm in women: prevalence, risk factors, and implications for screening. J Vasc Surg. 2007 Oct;46(4):630-635. doi: 10.1016/j.jvs.2007.06.024.

    PMID: 17903646BACKGROUND

  • US Preventive Services Task Force; Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, Caughey AB, Doubeni CA, Epling JW Jr, Kubik M, Landefeld CS, Mangione CM, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Abdominal Aortic Aneurysm: US Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-2218. doi: 10.1001/jama.2019.18928.

    PMID: 31821437BACKGROUND

  • Svensjo S, Bjorck M, Wanhainen A. Current prevalence of abdominal aortic aneurysm in 70-year-old women. Br J Surg. 2013 Feb;100(3):367-72. doi: 10.1002/bjs.8984. Epub 2012 Nov 28.

    PMID: 23192439BACKGROUND

  • Ghosh J, Murray D, Paravastu S, Farquharson F, Walker MG, Serracino-Inglott F. Contemporary management of aorto-iliac aneurysms in the endovascular era. Eur J Vasc Endovasc Surg. 2009 Feb;37(2):182-8. doi: 10.1016/j.ejvs.2008.11.001. Epub 2008 Nov 29.

    PMID: 19046903BACKGROUND

  • Maurel B, Bartoli MA, Jean-Baptiste E, Reix T, Cardon A, Goueffic Y, Martinez R, Cochennec F, Albertini JN, Chauffour X, Steinmetz E, Haulon S; Association Universitaire de Recherche en Chirurgie Vasculaire, France. Perioperative evaluation of iliac ZBIS branch devices: a French multicenter study. Ann Vasc Surg. 2013 Feb;27(2):131-8. doi: 10.1016/j.avsg.2011.02.052.

    PMID: 23380549BACKGROUND

  • Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.

    PMID: 29268916BACKGROUND

  • Faries PL, Morrissey N, Burks JA, Gravereaux E, Kerstein MD, Teodorescu VJ, Hollier LH, Marin ML. Internal iliac artery revascularization as an adjunct to endovascular repair of aortoiliac aneurysms. J Vasc Surg. 2001 Nov;34(5):892-9. doi: 10.1067/mva.2001.118085.

    PMID: 11700492BACKGROUND

  • Kouvelos GN, Katsargyris A, Antoniou GA, Oikonomou K, Verhoeven EL. Outcome after Interruption or Preservation of Internal Iliac Artery Flow During Endovascular Repair of Abdominal Aorto-iliac Aneurysms. Eur J Vasc Endovasc Surg. 2016 Nov;52(5):621-634. doi: 10.1016/j.ejvs.2016.07.081. Epub 2016 Sep 2.

    PMID: 27600731BACKGROUND

  • Cuypers PW, Laheij RJ, Buth J. Which factors increase the risk of conversion to open surgery following endovascular abdominal aortic aneurysm repair? The EUROSTAR collaborators. Eur J Vasc Endovasc Surg. 2000 Aug;20(2):183-9. doi: 10.1053/ejvs.2000.1167.

    PMID: 10944101BACKGROUND

  • Iwakoshi S, Nakai T, Ichihashi S, Inoue T, Sakaguchi S, Hirose T, Tabayashi N, Watkins AC, Kichikawa K. Conformability and Efficacy of the Zenith Spiral Z Leg Compared with the Zenith Flex Leg in Endovascular Abdominal Aortic Aneurysm Repair. Ann Vasc Surg. 2019 Aug;59:127-133. doi: 10.1016/j.avsg.2019.02.013. Epub 2019 May 7.

    PMID: 31071429BACKGROUND

  • Wolf YG, Tillich M, Lee WA, Rubin GD, Fogarty TJ, Zarins CK. Impact of aortoiliac tortuosity on endovascular repair of abdominal aortic aneurysms: evaluation of 3D computer-based assessment. J Vasc Surg. 2001 Oct;34(4):594-9. doi: 10.1067/mva.2001.118586.

    PMID: 11668310BACKGROUND

  • Parra JR, Ayerdi J, McLafferty R, Gruneiro L, Ramsey D, Solis M, Hodgson K. Conformational changes associated with proximal seal zone failure in abdominal aortic endografts. J Vasc Surg. 2003 Jan;37(1):106-11. doi: 10.1067/mva.2002.53.

    PMID: 12514585BACKGROUND

  • DeRoo E, Harris D, Olson S, Panthofer A, Meadows W, Pauli T, Peterson B, Schneider D, Matsumura J. Conformability of the GORE EXCLUDER iliac branch endoprosthesis is associated with freedom from adverse iliac events. J Vasc Surg. 2021 Nov;74(5):1558-1564.e1. doi: 10.1016/j.jvs.2021.05.026. Epub 2021 Jun 1.

    PMID: 34082005BACKGROUND

  • Panthofer AM, Olson SL, Rademacher BL, Grudzinski JK, Chaikof EL, Matsumura JS; N-TA(3)CT Investigators. Anatomic eligibility for endovascular aneurysm repair preserved over 2 years of surveillance. J Vasc Surg. 2021 Nov;74(5):1527-1536.e1. doi: 10.1016/j.jvs.2021.04.044. Epub 2021 May 4.

    PMID: 33957227BACKGROUND

  • Olson SL, Panthofer AM, Harris DJ, Jordan WD Jr, Farber MA, Cambria RP, Matsumura JS. CT-Derived Pretreatment Thoracic Sarcopenia Is Associated with Late Mortality after Thoracic Endovascular Aortic Repair. Ann Vasc Surg. 2020 Jul;66:171-178. doi: 10.1016/j.avsg.2019.10.089. Epub 2019 Nov 6.

    PMID: 31705993BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalIliac Aneurysm

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jon Matsumura, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 7, 2022

Study Start

November 1, 2014

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

April 19, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)