Abdominal Aortic AneurysmNCT04746677
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
A study testing Endovascular aortic repair with a physician-modified endovascular graft (PMEG) and TREO graft in people with Abdominal Aortic Aneurysm and Thoracoabdominal Aortic Aneurysm, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Dissection
- What is being tested?
- Endovascular aortic repair with a physician-modified endovascular graft (PMEG) and TREO graft
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jessica Kelliher, BSN, 617-632-9975, jjkellih@bilh.org
Marc L Schermerhorn, MD
About this study
Official title: Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
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.
Read the detailed description
Complex aortic pathology, comprised of aneurysmal disease and aortic dissection involving the visceral aortic segment, presents a technical challenge for repair due to involvement of the renal and/or mesenteric arteries. Traditionally, the gold standard for repair has been open repair. However, open repair of these diseases is associated with high perioperative morbidity and mortality. Therefore, for patients with significant medical comorbidities or complex surgical/anatomical features, the risk of open surgery may be prohibitive.
As endovascular techniques have become increasingly advanced, options for the endovascular treatment of complex aortic pathology involving the visceral segment have been developed. The predominant approach is fenestrated or branched endovascular aortic repair (F/B-EVAR) with fenestrated or branched endovascular grafts. Currently, there is only one device FDA-approved for commercial use in the United States, the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, IN). However, its use is limited by the design specifications of the device and the required manufacturing time in patients requiring more urgent repair. Therefore, many patients with complex aortic pathology are not eligible for repair with this device, and there are currently no other FDA-approved options for definitive repair.
One option for definitive repair of complex aortic pathology in patients ineligible for the Zenith fenestrated device is endovascular repair with a physician-modified endovascular graft (PMEG). For this procedure, the operating surgeon modifies an FDA-approved endovascular graft to incorporate fenestrations or branches based on the patient's anatomy. Numerous reports have been published demonstrating that this procedure can be performed with high technical success, and acceptable perioperative and mid-term results in high-risk patients.
The primary objective of the study is to evaluate safety and effectiveness of PMEGs for the endovascular repair of complex aortic pathology in high-risk patients. The safety outcomes include perioperative mortality (defined as death <30 days postoperative or during the index hospitalization) and major adverse events, along with mortality and adverse events during follow-up. Effectiveness outcomes include initial technical success, endoleak rate, target vessel patency, and rate of reintervention. Patients will be followed for five years. Patients will be evaluated preoperatively, at the time of the procedure, at the time of discharge from the index hospitalization, 1-month post-procedure, 6-months post-procedure, and 1-year post-procedure, and annually for five-years.
- Being tested
- Endovascular aortic repair with a physician-modified endovascular graft (PMEG), TREO graft
- Keywords
- Fenestrated endovascular aortic repair, Branched endovascular aortic repair, Complex aortic aneurysm repair
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)Device
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
TREO graftDevice
Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft
| Study group | Role | What they receive |
|---|---|---|
| Complex abdominal aortic aneurysm (AAA) | Experimental | Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm Receives: Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) |
| Thoracoabdominal aortic aneurysm (TAAA) | Experimental | Includes Type I, Type II, and Type III TAAA Receives: Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) |
| Type B aortic dissection | Experimental | Includes all Type B dissections Receives: Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) |
| Expanded Selection Arm | Experimental | Includes high risk subjects who do not meet inclusion criteria for Arms 1-3 Receives: Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) |
| Expanded Treatment | Experimental | Includes subjects who will have the PMEG TREO graft Receives: Device: TREO graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative mortality
Rate of death
Measured: Up to 30-days after surgery
Perioperative major adverse events
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
Measured: Up to 30-days after surgery
All-cause mortality
Rate of death due to any cause at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Aneurysm-related mortality
Rate of aneurysm-related death at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Long-term major adverse events
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)
Measured: 6-months to 5-years
Technical success
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
Measured: 24 hours
Device-related reintervention
Rate of device-related reintervention at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Aneurysm rupture
Rate of aneurysm rupture at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Conversion to open repair
Rate of conversion to open repair at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Endoleaks
Rate of Type I, II, III, IV, and V endoleaks at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Main device occlusion
Rate of main device occlusion at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Target vessel patency
Rate of target vessel patency at: 30-days, 6-months, 1-year, and annually to 5-years
Measured: 30-days to 5-years
Residual aneurysm sac status
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
Measured: 6-months, 1-year, and annually to 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start15 Mar 2021
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc L. Schermerhorn, MD, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746677
- Sponsor's protocol ID
- G200288
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Darling JD, Caron E, Park J, van Galen I, Guetter CR, Gomez-Mayorga J, Sanders AP, Stangenberg L, Schermerhorn ML. The effect of Fiber Optic RealShape technology on perioperative and postoperative outcomes following complex abdominal aortic repair. J Vasc Surg. 2025 Apr;81(4):830-838. doi: 10.1016/j.jvs.2024.12.037. Epub 2024 Dec 17.
PubMed 39694152Sanders AP, Gomez-Mayorga J, Manchella MK, Swerdlow NJ, Schermerhorn ML. Ten years of physician-modified endografts. J Vasc Surg. 2025 Jan;81(1):1-12.e1. doi: 10.1016/j.jvs.2024.07.108. Epub 2024 Aug 23.
PubMed 39181337Sanders AP, Swerdlow NJ, Yadavalli SD, Marcaccio CL, Stangenberg L, Schermerhorn ML. Reinterventions and sac dynamics after fenestrated endovascular aortic repair with physician-modified endografts for index aneurysm repair and following proximal failure of prior endovascular aortic repair. J Vasc Surg. 2024 Jun;79(6):1287-1294.e1. doi: 10.1016/j.jvs.2024.01.002. Epub 2024 Jan 5.
PubMed 38185213Sanders AP, Swerdlow NJ, Jabbour G, Schermerhorn ML. The effect of Fiber Optic RealShape technology on the reduction of radiation during complex endovascular surgery. J Vasc Surg. 2024 Apr;79(4):954-961. doi: 10.1016/j.jvs.2023.11.002. Epub 2023 Nov 4.
PubMed 37931886
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
- ClinicalTrials.gov ID
- NCT04746677
- Acronym / sponsor ID
- G200288
- Keywords
- Fenestrated endovascular aortic repair, Branched endovascular aortic repair, Complex aortic aneurysm repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Complex aortic pathology, comprised of aneurysmal disease and aortic dissection involving the visceral aortic segment, presents a technical challenge for repair due to involvement of the renal and/or mesenteric arteries. Traditionally, the gold standard for repair has been open repair. However, open repair of these diseases is associated with high perioperative morbidity and mortality. Therefore, for patients with significant medical comorbidities or complex surgical/anatomical features, the risk of open surgery may be prohibitive.
As endovascular techniques have become increasingly advanced, options for the endovascular treatment of complex aortic pathology involving the visceral segment have been developed. The predominant approach is fenestrated or branched endovascular aortic repair (F/B-EVAR) with fenestrated or branched endovascular grafts. Currently, there is only one device FDA-approved for commercial use in the United States, the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, IN). However, its use is limited by the design specifications of the device and the required manufacturing time in patients requiring more urgent repair. Therefore, many patients with complex aortic pathology are not eligible for repair with this device, and there are currently no other FDA-approved options for definitive repair.
One option for definitive repair of complex aortic pathology in patients ineligible for the Zenith fenestrated device is endovascular repair with a physician-modified endovascular graft (PMEG). For this procedure, the operating surgeon modifies an FDA-approved endovascular graft to incorporate fenestrations or branches based on the patient's anatomy. Numerous reports have been published demonstrating that this procedure can be performed with high technical success, and acceptable perioperative and mid-term results in high-risk patients.
The primary objective of the study is to evaluate safety and effectiveness of PMEGs for the endovascular repair of complex aortic pathology in high-risk patients. The safety outcomes include perioperative mortality (defined as death <30 days postoperative or during the index hospitalization) and major adverse events, along with mortality and adverse events during follow-up. Effectiveness outcomes include initial technical success, endoleak rate, target vessel patency, and rate of reintervention. Patients will be followed for five years. Patients will be evaluated preoperatively, at the time of the procedure, at the time of discharge from the index hospitalization, 1-month post-procedure, 6-months post-procedure, and 1-year post-procedure, and annually for five-years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Complex abdominal aortic aneurysm (AAA) | Experimental | Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm |
| Thoracoabdominal aortic aneurysm (TAAA) | Experimental | Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)Includes Type I, Type II, and Type III TAAA |
| Type B aortic dissection | Experimental | Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)Includes all Type B dissections |
| Expanded Selection Arm | Experimental | Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)Includes high risk subjects who do not meet inclusion criteria for Arms 1-3 |
| Expanded Treatment | Experimental | Device: TREO graftIncludes subjects who will have the PMEG TREO graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular aortic repair with a physician-modified endovascular graft (PMEG)Endovascular aortic repair with a physician-modified endovascular graft (PMEG) | Device | Complex abdominal aortic aneurysm (AAA), Expanded Selection Arm, Thoracoabdominal aortic aneurysm (TAAA), Type B aortic dissection |
| TREO graftEndovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft | Device | Expanded Treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 39694152Darling JD, Caron E, Park J, van Galen I, Guetter CR, Gomez-Mayorga J, Sanders AP, Stangenberg L, Schermerhorn ML. The effect of Fiber Optic RealShape technology on perioperative and postoperative outcomes following complex abdominal aortic repair. J Vasc Surg. 2025 Apr;81(4):830-838. doi: 10.1016/j.jvs.2024.12.037. Epub 2024 Dec 17.
- Derived from this study: PubMed 39181337Sanders AP, Gomez-Mayorga J, Manchella MK, Swerdlow NJ, Schermerhorn ML. Ten years of physician-modified endografts. J Vasc Surg. 2025 Jan;81(1):1-12.e1. doi: 10.1016/j.jvs.2024.07.108. Epub 2024 Aug 23.
- Derived from this study: PubMed 38185213Sanders AP, Swerdlow NJ, Yadavalli SD, Marcaccio CL, Stangenberg L, Schermerhorn ML. Reinterventions and sac dynamics after fenestrated endovascular aortic repair with physician-modified endografts for index aneurysm repair and following proximal failure of prior endovascular aortic repair. J Vasc Surg. 2024 Jun;79(6):1287-1294.e1. doi: 10.1016/j.jvs.2024.01.002. Epub 2024 Jan 5.
- Derived from this study: PubMed 37931886Sanders AP, Swerdlow NJ, Jabbour G, Schermerhorn ML. The effect of Fiber Optic RealShape technology on the reduction of radiation during complex endovascular surgery. J Vasc Surg. 2024 Apr;79(4):954-961. doi: 10.1016/j.jvs.2023.11.002. Epub 2023 Nov 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular aortic repair with a physician-modified endovascular graft (PMEG) and TREO graft in people with Abdominal Aortic Aneurysm and Thoracoabdominal Aortic Aneurysm, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kelliher, BSN (617-632-7845, jjkellih@bilh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative mortality (time frame: Up to 30-days after surgery). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746677, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.