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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is ≥ 18 years of age

• Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)

• Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form

• Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

∙ An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements

‣ Aneurysm with a history of growth \> 0.5 cm in 6 months

‣ Saccular aneurysm deemed at significant risk for rupture

‣ Symptomatic aneurysm

‣ Ruptured aneurysm

• Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.

• Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.

• Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.

• Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.

• Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.

⁃ Patient has juxtarenal aortic neck angulation ≤ 60°

⁃ Target branch vessel diameter ≥ 5 mm.

⁃ Patient must be willing to comply with all required follow-up exams.

Locations
United States
Connecticut
Hartford Hospital
RECRUITING
Hartford
Contact Information
Primary
Akhilesh K Jain, MD
akhilesh.jain@hhchealth.org
860-522-4158
Backup
Vicky McLeod, BS
Vicky.MacLeod@hhchealth.org
860-972-5799
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2032-05-01
Participants
Target number of participants: 15
Treatments
Experimental: Treatment arm
Sponsors
Leads: Akhilesh Jain

This content was sourced from clinicaltrials.gov