Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptu
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
| Condition(s) | Juxta Renal Abdominal Aortic Aneurysm Without Rupture, Complex Aortic Aneurysms, Aortic Aneurysm |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Patient is ≥ 18 years of age 2. 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) 3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following: 1. 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 2. Aneurysm with a history of growth \> 0.5 cm in 6 months 3. Saccular aneurysm deemed at significant risk for rupture 4. Symptomatic aneurysm 5. Ruptured an |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Akhilesh Jain |
| Locations | Hartford, Connecticut, United States |
| Start date | 2025-06-01 |
| NCT ID | NCT06834607 |
| Official listing | https://clinicaltrials.gov/study/NCT06834607 |