NCT07224230: PMEG

Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients

Recruiting now NA Last updated 21 January 2026

What this trial tests

NA trial testing Physician Modified Endograft in Abdominal Aortic Aneurysms in 15 participants. Currently enrolling.

Timeline

1 September 2025

Primary endpoint
1 September 2026

1 September 2030

Quick facts

Lead sponsor	Steven Maximus
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 September 2025
Primary completion	1 September 2026
Estimated completion	1 September 2030
Sites	1 location across United States

Drugs / interventions tested

• Physician Modified Endograft

Conditions studied

• Abdominal Aortic Aneurysms — all drugs for Abdominal Aortic Aneurysms →
• Thoracoabdominal Aneurysms — all drugs for Thoracoabdominal Aneurysms →
• Pararenal Aortic Aneurysm — all drugs for Pararenal Aortic Aneurysm →

Sponsor

Steven Maximus

Who can join

18 and older, any sex, with Abdominal Aortic Aneurysms or Thoracoabdominal Aneurysms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair. C) Are high-risk subjects with previously placed endovascular devices and have developed failure of their previous devices. The use of physician-modified endografts aims to shift the seal zone proximally above the celiac artery in order to treat their complex or thoracoabdominal aneurysms in a minimally invasive fashion. These patients are considered too high risk to survive open surgical repair and do not meet anatomic criteria for the Gore Thoracoabdominal Multi Branch Endoprosthesis, which is currently the only FDA approved device in the US to treat these aneurysms.

The primary objective is to evaluate safety and effective of physician modified endografts in the treatment of thorax-abdominal aneurysms and complex aortic aneurysms. For primary safety endpoints, mortality and major adverse events (MAE) will be analyzed at 30 days or in hospitalization (if this exceeds 30 days). Primary endpoints include the following: 1. Mortality related to primary aortic disease 2. Aneurysm rupture 3. All cause mortality

For primary effectiveness endpoints, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12 months. Treatment success is defined by a composite endpoint, which includes all of the following criteria: Technical success (defined as successful delivery and deployment of the physician modified endograft with perseveration of those branch vessels intended to be preserved, freedom from type I or type III endoleak, freedom from stent graft migration, freedom from aneurysm enlargement \>5mm, freedom from aneurysm rupture or conversion to open repair.

Secondary objectives of the study include assessment of individual safety and effectiveness endpoints as follows: technical success, procedure success, mortality, major adverse events - specifically renal, cardia, pulmonary, gastrointestinal, and neurologic. Each endpoint will be analyzed separately. Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years.

Secondary endpoints to be analyzed are the following: 1. Evidence of Aortic Disease Progression: Monitoring for aneurysm growth \> 5 mm from baseline measurements. 2. Device Failure: Evaluation of device performance, including migration \> 10 mm, device degradation, and loss of device integrity. 3. Endoleaks: Monitoring for the occurrence and classification of endoleaks as outlined in the clinical outcome definitions. 4. Secondary Interventions: Description and analysis of secondary interventions aimed at treating branch vessel stenosis, occlusion, or embolization. 5. Significant Lifestyle-Limiting or Disabling Complications: Assessment and reporting of complications resulting in significant impairment of daily life, such as stroke-induced paralysis (paraplegia). 6. Cardiac Dysfunction: Monitoring and analysis of cardiac events, including myocardial infarction, congestive heart failure, and cardiac ischemia requiring intervention. 7. Renal Events: Evaluation of renal complications, including the need for dialysis, deterioration of renal function, and renal failure. 8. Mesenteric Events: Description and classification of mesenteric complications, such as ischemia and the need for surgical resection. 9. Respiratory Events: Monitoring for respiratory complications, including respiratory failure and prolonged intubation

Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years

Publications & conference data

No peer-reviewed publications indexed yet for this trial.