Physician-modified endograft repair for complex abdominal and thoracoabdominal aortic aneurysms in high-risk patients

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

This study will try physician-modified endografts to repair complex abdominal and thoracoabdominal aortic aneurysms in patients who are too high-risk for open surgery and do not meet criteria for currently approved devices.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07224230 on ClinicalTrials.gov

What this trial studies

This single-arm, FDA-monitored protocol tests physician-modified endografts (PMEGs) using Cook Medical Zenith components altered by physicians to treat complex pararenal and thoracoabdominal aneurysms in patients unsuitable for standard approved devices. The procedure shifts the proximal seal zone above the celiac artery and may use modular graft pieces or previously placed grafts to create secure proximal and distal seals. Device sizing is guided by preoperative CT (and angiography if needed) with 15–25% oversizing to reduce migration and endoleak risk, and patients are followed for safety and effectiveness outcomes. Enrollment is limited to adults judged too high-risk for open repair who lack anatomically suitable options with currently marketed endografts, and procedures are performed at Baylor College of Medicine under FDA oversight.

Who should consider this trial

Good fit: Ideal candidates are adults with complex abdominal, pararenal, or thoracoabdominal aortic aneurysms who are high risk for open repair, cannot be treated with currently approved non-modified devices, and have adequate femoral or iliac access for endovascular delivery.

Not a fit: Patients who have anatomy treatable with approved off-the-shelf endografts, who are low-risk for standard open repair, or who lack suitable vascular access are unlikely to benefit from this physician-modified approach.

Why it matters

Potential benefit: If successful, this approach could allow patients who are not candidates for approved devices or open surgery to receive a less invasive repair that may reduce perioperative morbidity and mortality.

How similar studies have performed: Physician-modified endografts have been reported in registries and case series with encouraging short-term technical success and acceptable complication rates, but large-scale FDA-monitored evidence is limited.

Eligibility criteria

Inclusion Criteria:

* Patient is \> 18 years of age.
* Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study)
* Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
* The subject has at least one of the following:

  1. . An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females
  2. Aortic Aneurysm with a history of growth ≥ 0.5 cm in 6 mos.
  3. Symptomatic aneurysm
  4. Morphology such as saccular aneurysms
  5. Aneurysms meeting any of the above criteria a-e above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.
* Cannot be treated with a currently available non-modified approved device.
* Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified graft or is suitable for an iliac conduit.
* Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20mm.
* Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥15mm.
* The resultant repair should preserve patency in at least one hypogastric artery.
* Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20mm.
* Chronic Dissection with aneurysmal degeneration that meets size criteria as described above for repair
* Type 1A endoleak requiring extension above the previous repair into the pararenal or paravisceral portion of the aorta to achieve 2 cm of seal.

Exclusion Criteria:

* patient has a mycotic aneurysm
* patient has a systemic or local infection that may increase the risk of graft infection.
* Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
* Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair.
* Patient is currently participating in another investigational device or drug clinical trial.
* Eligible for treatment with FDA-approved marketed device
* Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturermade device at another institution.
* Unwilling to comply with the follow-up schedule.
* Inability or refusal to give informed consent by subject or legal representative. - The subject is pregnant or breastfeeding.
* Known sensitivities or allergies to the materials of construction of the devices, including stainless steel, polyester, polypropylene, nickel, titanium, or gold. - Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pretreatment
* Uncorrectable coagulopathy
* Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
* Systemic or local infection that may increase the risk of endovascular graft infection.
* History of connective tissue disorders (e.g., Marfan Syndrome, Ehlers's Danlos Syndrome) without landing zone created from graft via previous open repair. - Patient has active malignancy with life expectancy of less than 2 years.
* Patient has a limited life expectancy of less than 2 years.
* Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations.
* Anatomical exclusion criteria such as significant occlusive disease, tortuosity or calcification that would prevent endovascular access.
* proximal seal site with a circumferential thrombus/atheroma
* inability to maintain at least one hypogastric artery.
* shaggy aorta
* patient is not amenable to a temporary or permanent open surgical or endovascular conduit.
* Thrombus or excessive calcification within the neck of the aneurysm

Where this trial is running

Houston, Texas

• Baylor College of Medicine — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Steven Maximus, MD — Baylor College of Medicine
• Study coordinator: Andrea Martinez

Conditions Abdominal Aortic Aneurysms; Thoracoabdominal Aneurysms; Pararenal Aortic Aneurysm; PMEG; abdominal aortic aneurysms; thoracoabdominal aneurysms; pararenal aortic aneurysms