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

NCT04746677 | Recruiting DMC FDA Device

• 1 other identifier: G200288
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Aortic Dissection

Keywords

Fenestrated endovascular aortic repair; Branched endovascular aortic repair; Complex aortic aneurysm repair

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (5)

Complex abdominal aortic aneurysm (AAA)

EXPERIMENTAL

Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm

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

Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)

Type B aortic dissection

EXPERIMENTAL

Includes all Type B dissections

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

Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)

Expanded Treatment

EXPERIMENTAL

Includes subjects who will have the PMEG TREO graft

Device: TREO graft

Interventions

Endovascular aortic repair with a physician-modified endovascular graft (PMEG) DEVICE

Endovascular aortic repair with a physician-modified endovascular graft (PMEG)

Complex abdominal aortic aneurysm (AAA); Expanded Selection Arm; Thoracoabdominal aortic aneurysm (TAAA); Type B aortic dissection

TREO graft DEVICE

Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft

Expanded Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• Known sensitivities or allergies to the materials of construction of the devices

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal; Aortic Dissection

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Central Study Contacts

Jessica Kelliher, BSN

CONTACT

617-632-7845; jjkellih@bilh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Vascular and Endovascular Surgery

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 10, 2021
• Study Start: March 15, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)