NCT04746677 · Beth Israel Deaconess Medical Center
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
What this study is about
The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients.
View original scientific description
The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.
Interventions
DEVICE
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
DEVICE
TREO graft
Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft
Primary outcome measures
Perioperative mortality
Time frame: Up to 30-days after surgery
Rate of death
Perioperative major adverse events
Time frame: Up 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 mortality
Time frame: 30-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 mortality
Time frame: 30-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 events
Time frame: 6-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 success
Time frame: 24 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 reintervention
Time frame: 30-days to 5-years
Rate of device-related reintervention at: 30-days, 6-months, 1-year, and annually to 5-years
Aneurysm rupture
Time frame: 30-days to 5-years
Rate of aneurysm rupture at: 30-days, 6-months, 1-year, and annually to 5-years
Conversion to open repair
Time frame: 30-days to 5-years
Rate of conversion to open repair at: 30-days, 6-months, 1-year, and annually to 5-years
Endoleaks
Time frame: 30-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 occlusion
Time frame: 30-days to 5-years
Rate of main device occlusion at: 30-days, 6-months, 1-year, and annually to 5-years
Target vessel patency
Time frame: 30-days to 5-years
Rate of target vessel patency at: 30-days, 6-months, 1-year, and annually to 5-years
Residual aneurysm sac status
Time frame: 6-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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- General inclusion criteria (applicable to all 3 study arms):
- 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 Arm1:
- 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 Arm2:
- 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 Arm 3:
- 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 Arm 4
- Patient does not meet the inclusion/
Exclusion criteria
- of Arms 1 - 3
- 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 CRITERIA: General Exclusion Criteria
- 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 Arm 5 • Patient meets criteria for Arms 1-4 \- Patient is undergoing repair using the TREO bifurcated stent graft Indications for using TREO bifurcated stent graft:
- 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. Medical Exclusion Criteria
- 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) Anatomic Exclusion Criteria
- 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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations