Physician Modified Endovascular Grafts

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT01538056
Status
Recruiting
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Conditions

  • Abdominal Aortic Aneurysms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fenestrated Endovascular Graft or Company Manufactured Terumo Aortic Fenestrated TREO Endovascular Graft — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2011
Status verified
Jan 2026
Primary completion
Jan 31, 2045
Completion
Jan 31, 2055

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PMEG Fenestrated Graft or Company Manufactured Terumo Aortic Fenestrated TREO Graft
    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.

Primary Outcome Measure

Primary Safety Endpoints [ Time Frame: Index Procedure through 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harborview Medical CenterSeattleWashington98104
Allison Larimore, MSN, RN
[email protected]
206-744-8257
Benjamin W Starnes, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Harborview Medical Center· Seattle, WA

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