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Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
NCT07019454 · View on ClinicalTrials.gov ↗
Study Summary
Patients who are found to have an aneurysm (bulge) in the abdominal aorta, which is the blood vessel in your abdomen (belly) that supplies blood to most of your lower body, including major organs and your legs. As an aneurysm expands, the walls of the aorta become weak and may rupture (break open), causing a major loss of blood with a high risk of serious problems and death. To avoid this risk, doctors repair aneurysms by either open surgery (incision) or endovascular surgery (covered stents to channel the blood flow). Juxtarenal aneurysms (those that come close to the kidney arteries) present a unique challenge as they are more dangerous to repair by open therapy and do not fit the standard approved endovascular devices. The purpose of this study is to assess the effects of the physician-modified endovascular graft (PMEG) by collecting information about the performance of this investigational medical device. The main graft looks like a pair of pants with very short legs. The top of the pants is placed in the aorta. Then, two smaller grafts go from the main graft and to your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is packed into a small catheter (a long, flexible plastic tube) that is placed into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. These grafts are investigational because the research physician has changed them to match patient anatomy (body make up) while protecting blood flow to important vessels. Once the grafts are attached inside the aorta, they will support the area of the aorta that is weakened and bulging. Modifications of the graft will include between one and four holes (fenestrations) near the top of the graft. The holes allow the graft to be located above the renal arteries (the blood vessels that supply blood to your kidneys) witho
Conditions Studied
Interventions
- DEVICE Physician Modified Endografting
Study Locations (1)
Massachusetts
- Baystate Medical Center — Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-06-03 |
| Est. Completion | 2035-06-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07019454
The ClinicalTrials.gov registry entry for NCT07019454 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 Baystate Medical Center, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Technical Sucess appearing as the primary indexed condition, and to 1 intervention — of which Physician Modified Endografting 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: NCT07019454 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. 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 NCT07019454 about?
NCT07019454 is a clinical study titled "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms". Patients who are found to have an aneurysm (bulge) in the abdominal aorta, which is the blood vessel in your abdomen (belly) that supplies blood to most of your lower body, including major organs and your legs. As an aneurysm expands, the walls of the aorta become weak and may rupture (break open), ...
What is the current status of trial NCT07019454?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-06-03. Estimated completion is 2035-06-03.
What conditions does trial NCT07019454 study?
This clinical trial studies the following conditions: Technical Sucess, Freedom From Type I and III Endoleaks at 12 Months, Freedom From Stent Graft Migration at 12 Months, Freedom From Aortic Aneurysm Enlargement at 12 Months, Freedom From Aortic Aneurysm Rupture or Conversion to Open Repair at 12 Months. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07019454?
The interventions under investigation include: Physician Modified Endografting (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07019454?
This trial is sponsored by Baystate Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07019454 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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