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NCT07224230 · ClinicalTrials.gov registry record · NA
Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients
A NA study of Abdominal Aortic Aneurysms and Thoracoabdominal Aneurysms, sponsored by Steven Maximus.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT07224230 is a NA study of Abdominal Aortic Aneurysms and Thoracoabdominal Aneurysms that is actively recruiting participants, run by Steven Maximus. The registered enrollment target is 15 participants, below the 200-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07224230, a NA study of Abdominal Aortic Aneurysms and Thoracoabdominal Aneurysms, is actively recruiting participants, sponsored by Steven Maximus.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
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 an
Conditions Studied
Interventions
- DEVICE Physician Modified Endograft
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2030-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07224230
The ClinicalTrials.gov registry entry for NCT07224230 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (92% lower). The listed sponsor is Steven Maximus, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Abdominal Aortic Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which Physician Modified Endograft is the first listed.
NCT07224230 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07224230 about?
NCT07224230 is a clinical study titled "Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients". 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 repa...
What is the current status of trial NCT07224230?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-09-01. Estimated completion is 2030-09-01.
What conditions does trial NCT07224230 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysms, Thoracoabdominal Aneurysms, Pararenal Aortic Aneurysm.
What interventions are being tested in trial NCT07224230?
The interventions under investigation include: Physician Modified Endograft (DEVICE).
Who is sponsoring clinical trial NCT07224230?
This trial is sponsored by Steven Maximus, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07224230 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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