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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection; Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm
• Intervention / Treatment: Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG); Device: TREO graft

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 Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Kelliher, BSN; Phone Number: 617-632-7845; Email: jjkellih@bilh.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Marc L Schermerhorn, MD
      • Sub-Investigator: Lars Stangenberg, MD
      • Contact: Jessica Kelliher, BSN; Phone Number: 617-632-9975; Email: jjkellih@bilh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complex abdominal aortic aneurysm (AAA); Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm	Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG); Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Experimental: Thoracoabdominal aortic aneurysm (TAAA); Includes Type I, Type II, and Type III TAAA	Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG); Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Experimental: Type B aortic dissection; Includes all Type B dissections	Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG); Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Experimental: Expanded Selection Arm; Includes high risk subjects who do not meet inclusion criteria for Arms 1-3	Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG); Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Experimental: Expanded Treatment; Includes subjects who will have the PMEG TREO graft	Device: TREO graft; Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative mortality	Rate of death	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	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	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	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)	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	24 hours
Device-related reintervention	Rate of device-related reintervention at: 30-days, 6-months, 1-year, and annually to 5-years	30-days to 5-years
Aneurysm rupture	Rate of aneurysm rupture at: 30-days, 6-months, 1-year, and annually to 5-years	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	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	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	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	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	6-months, 1-year, and annually to 5-years

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fenestrated endovascular aortic repair; Branched endovascular aortic repair; Complex aortic aneurysm repair
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal; Aortic Dissection; Aortic Aneurysm, Abdominal; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Vascular Grafting; Prosthesis Implantation; Blood Vessel Prosthesis Implantation; Endovascular Aneurysm Repair
• Other Study ID Numbers: G200288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes