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Study of Physician-Modified Endovascular Grafts for Complex Aortic Conditions

This study is looking at the safety and effectiveness of a special type of graft called a physician-modified endovascular graft (PMEG) for repairing complex problems with the aorta (the body's main artery). This includes conditions like abdominal aortic aneurysm, thoracoabdominal aortic aneurysm, and aortic dissection. These grafts are used when standard, FDA-approved devices aren't suitable. The study aims to see if these PMEGs, including the TREO graft, can help patients who are at high risk for traditional open surgery. Researchers will measure how many patients die or have major problems within 30 days of surgery, and overall survival for up to 5 years. You may be able to join if you are 21 or older and have one of these aortic conditions that cannot be treated with standard devices. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 220 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 30 days after surgery for perioperative outcomes, and for all-cause mortality from 30 days up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04746677

Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

Recruiting
NAAges 21+InterventionalTreatment
Beth Israel Deaconess Medical Center
~220 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Endovascular aortic repair with a physician-modified endovascular graft (PMEG)TREO graft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perioperative mortality
Measured over Up to 30-days after surgery
+12 more outcomes measured

Conditions

Abdominal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Aortic Dissection

Explore related trials

Abdominal Aortic AneurysmAortic DissectionThoracoabdominal aortic aneurysm

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Jessica Kelliher, BSN
[email protected]
617-632-7845
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aortic pathology that fits one of the study arms (see below for detailed description)
Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device
Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing
Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity
Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit
Non-aneurysmal aortic segment proximal to the aortic pathology with a:
Minimum neck length of 20 mm
Diameter between 20 - 42 mm
Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:
Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm
Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm
Age ≥21 years old
Life expectancy: ≥2 years
Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm
Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus
Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease above the diaphragmatic hiatus
Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture
Symptomatic complex aortic aneurysm
Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months
Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair with aneurysmal disease extending above the diaphragmatic hiatus
Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair
Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, with aneurysmal disease above the diaphragmatic hiatus
Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture
Symptomatic type I, II, or III thoracoabdominal aortic aneurysm
Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy
Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)
Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy
Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option
Estimated perioperative risk is lower than the estimated 1-year mortality without surgery

Exclusion

Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
Subject is unwilling to comply with the follow-up schedule
Inability or refusal to give informed consent by subject or legal representative
Subject is pregnant or breastfeeding
Subject has a ruptured aneurysm
Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR
-Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) \< 115 mm; OR
In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR
Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha/Alpha 2 endograft.
Known sensitivities or allergies to the materials of construction of the devices
Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
Uncorrectable coagulopathy
Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
Systemic or local infection that may increase the risk of endovascular graft infection
Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
Inability to perform open or endovascular iliac conduit in patients with inadequate femoral/iliac access
Excessive thrombus or calcification within the neck of the aneurysm
Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size

What this trial measures

  • Perioperative mortalityUp to 30-days after surgery

    Rate of death

  • Perioperative major adverse eventsUp to 30-days after surgery

    Rates of: * Stroke * Respiratory failure (defined as postoperative intubation \>48 hours or reintubation) * Myocardial infarction * Bowel ischemia requiring treatment * Renal failure requiring dialysis * Acute limb ischemia * Paraplegia

  • All-cause mortality30-days to 5-years

    Rate of death due to any cause at: 30-days, 6-months, 1-year, and annually to 5-years

  • Aneurysm-related mortality30-days to 5-years

    Rate of aneurysm-related death at: 30-days, 6-months, 1-year, and annually to 5-years

  • Long-term major adverse events6-months to 5-years

    Rate of major adverse events at: 6-months, 1-year, and annually to 5-years Long-term major adverse event is defined as having at least one of the following: * Death * Stroke (deemed related to the device, the procedure, or a reintervention) * Bowel ischemia requiring treatment (deemed related to the device, the procedure, or a reintervention) * Renal failure requiring dialysis (deemed related to the device, the procedure, reintervention, or follow-up imaging) * Acute limb ischemia (deemed related to the device, the procedure, or a reintervention)

  • Technical success24 hours

    Defined as successful delivery of the physician-modified graft in the planned location with patency of all intended target vessels and without unintentional coverage of any aortic branches, along with successful removal of the delivery system

  • Device-related reintervention30-days to 5-years

    Rate of device-related reintervention at: 30-days, 6-months, 1-year, and annually to 5-years

  • Aneurysm rupture30-days to 5-years

    Rate of aneurysm rupture at: 30-days, 6-months, 1-year, and annually to 5-years

  • Conversion to open repair30-days to 5-years

    Rate of conversion to open repair at: 30-days, 6-months, 1-year, and annually to 5-years

  • Endoleaks30-days to 5-years

    Rate of Type I, II, III, IV, and V endoleaks at: 30-days, 6-months, 1-year, and annually to 5-years

  • Main device occlusion30-days to 5-years

    Rate of main device occlusion at: 30-days, 6-months, 1-year, and annually to 5-years

  • Target vessel patency30-days to 5-years

    Rate of target vessel patency at: 30-days, 6-months, 1-year, and annually to 5-years

  • Residual aneurysm sac status6-months, 1-year, and annually to 5-years

    Rate of residual sac status (stable, regressing, expanding) at 6-months, 1-year, and annually to 5-years, defined as the following: * Stable: maximum diameter within 5 mm of the diameter at 30-day follow-up * Regressing: maximum diameter ≥5 mm less than the diameter at 30-day follow-up * Expanding: maximum diameter ≥5 mm greater than the diameter at 30-day follow-up