Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Akhilesh Jain
Study ID
NCT06834607
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Aneurysm
  • Complex Aortic Aneurysms
  • Juxta Renal Abdominal Aortic Aneurysm Without Rupture

Eligibility Criteria

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

Interventions

  • Physician Modified Aortic Endograft repair for complex aortic aneurysm — DEVICE
    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.

Study Details

The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.

Key Dates

Start date
Jun 1, 2025
Status verified
Aug 2025
Primary completion
May 1, 2027
Completion
May 1, 2032

Study Design

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

Arms

  • Experimental: Treatment arm

Primary Outcome Measure

Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure. [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06102
Akhilesh K Jain, MD, FACS, FSVS
[email protected]
860-522-4158
Vicky McLeod
[email protected]
860-972-5799
Akhilesh K Jain, MD, FACS, FSVS (PRINCIPAL_INVESTIGATOR)

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By research site
Hartford Hospital· Hartford, CT

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