Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06657794
Status
Recruiting
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Conditions

  • Aortic Rupture
  • Juxtarenal Aortic Aneurysm

Eligibility Criteria

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

Interventions

  • Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system — DEVICE
    A Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques.

Study Details

The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device: * acutely (i.e., treatment success and technical success); * at 30 days (i.e., the rate of major adverse events (MAE)); and * at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).

Key Dates

Start date
Feb 17, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Intervention
    Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system

Primary Outcome Measure

Major Adverse Events [ Time Frame: Up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Yuki Kuramochi, BSN, RN
[email protected]
Francis Caputo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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