NCT01538056|RecruitingDMCFDA Device
Physician Modified Endovascular Grafts
PMEG
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Sponsor study identifier
interventional
500
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2045
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2055
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured investigational devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2055
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 18, 2012
Actual (reported)February 23, 2012
Actual (reported)January 2045
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2055
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Safety Endpoints
The safety of physician modified endovascular grafts will be determined by evaluating the proportion of patients that experience a rate of Major Adverse Events.
Index Procedure through 12 Months
Primary Effectiveness Endpoint
The primary effectiveness endpoint is the proportion of treatment group subjects that achieve technical and treatment success.
Index Procedure through 12 Months
Primary Technical Success Endpoint
Successful delivery and deployment of the investigational device with preservation of those branch vessels intended to be preserved at the study Index Procedure.
Index Procedure
Primary Treatment Success Endpoint
All the following composite endpoint criteria to be met in order for a patient to be considered a treatment success: Technical Success, Freedom from Type I \& III endoleak, Freedom from stent graft migration \>10mm, Freedom from AAA enlargement \>5mm, Freedom from AAA rupture, Freedom from surgical conversion to open repair
Index Procedure through 12 Months
Secondary Safety Endpoint
Index Procedure, 12 months, End of Study, Lifespan
Secondary Stent Graft Effectiveness Endpoint
Index Procedure through Lifespan
Secondary Clinical Utility Assessment Endpoint(s)
Index Procedure
See Interventions for more details. Participants who sign the informed consent form and exit the study at any timepoint will be followed via chart review for their lifespan.
PMEG Fenestrated Device- Physician modified fenestrations for the bilateral renal arteries, celiac and SMA. May include several fenestrations or only one with or without the use of the Terumo Aortic TREOFit 3-D Printed Template for fenestration placement. Company Manufactured Device - Terumo Aortic Fenestrated TREO Abdominal Stent Graft System fenestrated for the bilateral renal arteries, celiac and SMA. May be in the straight or tapered configurations based on patient anatomical needs.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Harborview Medical Center
Seattle, Washington, 98104, United States
Stafforini NA, Zettervall SL, Larimore A, Starnes BW. Durability of a physician-modified endograft constructed using the Terumo Aortic TREO device: A postmortem evaluation. J Vasc Surg Cases Innov Tech. 2026 Aug 14;12(6):102450. doi: 10.1016/j.jvscit.2026.102450. eCollection 2026 Dec.
Murphy BE, Anderson G, Phocas A, Bains J, Larimore A, Singh N, Starnes BW, Zettervall SL. Cause of death among patients following repair of juxtarenal aneurysm with physician-modified endografts. J Vasc Surg. 2025 Jun;81(6):1298-1308. doi: 10.1016/j.jvs.2025.02.016. Epub 2025 Feb 19.
Benjamin W Starnes, MD
University of Washington
First Submitted
February 18, 2012
First Posted
February 23, 2012
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2045
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
Contact the study team to confirm eligibility.
Saldana-Ruiz N, Tachida A, Mossman A, Cure R, Larimore A, Dansey K, Starnes BW, Zettervall SL. Iliac tortuosity increases reinterventions but not adverse outcomes following repair of juxtarenal aneurysms using physician-modified endografts. J Vasc Surg. 2024 Mar;79(3):497-505. doi: 10.1016/j.jvs.2023.10.053. Epub 2023 Nov 3.
Tachida A, Stafforini N, Singh N, Starnes B, Zettervall SL. Reinterventions after physician-modified endovascular grafts for treatment of juxtarenal aortic aneurysms are non-detrimental to long-term survival. J Vasc Surg. 2023 May;77(5):1367-1374.e2. doi: 10.1016/j.jvs.2022.12.061. Epub 2023 Jan 7.
Zettervall SL, Dansey K, Kline B, Singh N, Starnes BW. Significant aortic neck dilation occurs after repair of juxtarenal aneurysms with fenestrated endovascular aneurysm repair. J Vasc Surg. 2021 Oct;74(4):1090-1097.e2. doi: 10.1016/j.jvs.2021.03.060. Epub 2021 Apr 28.
Hemingway JF, Starnes BW, Kline BR, Singh N. Initial experience with the Terumo aortic Treo device for fenestrated endovascular aneurysm repair. J Vasc Surg. 2021 Sep;74(3):823-831.e1. doi: 10.1016/j.jvs.2021.01.042. Epub 2021 Feb 14.
Hurd JR, Chen X, Caps MT, Katsman D, Singh N, Zierler RE, Tatum B, Starnes BW. A reliable method for renal volume measurement and its application in fenestrated endovascular aneurysm repair. J Vasc Surg. 2020 May;71(5):1515-1520. doi: 10.1016/j.jvs.2019.07.089. Epub 2019 Oct 18.
Starnes BW, Tatum B. Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. J Vasc Surg. 2013 Aug;58(2):311-7. doi: 10.1016/j.jvs.2013.01.029. Epub 2013 May 3.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2055
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 12, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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