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Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients
NCT07224230 · View on ClinicalTrials.gov ↗
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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steven Maximus, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07224230 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07224230?
The interventions under investigation include: Physician Modified Endograft (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07224230?
This trial is sponsored by Steven Maximus, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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