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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT04746677
Status
Recruiting
Apply to this trial

Conditions

  • Abdominal Aortic Aneurysm
  • Aortic Dissection
  • Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 15, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Complex abdominal aortic aneurysm (AAA)
    Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm
  • Experimental: Thoracoabdominal aortic aneurysm (TAAA)
    Includes Type I, Type II, and Type III TAAA
  • Experimental: Type B aortic dissection
    Includes all Type B dissections
  • Experimental: Expanded Selection Arm
    Includes high risk subjects who do not meet inclusion criteria for Arms 1-3
  • Experimental: Expanded Treatment
    Includes subjects who will have the PMEG TREO graft

Primary Outcome Measure

Perioperative mortality [ Time Frame: Up to 30-days after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jessica Kelliher, BSN
[email protected]
617-632-9975
Marc L Schermerhorn, MD (PRINCIPAL_INVESTIGATOR)
Lars Stangenberg, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MA

Related Studies