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

ConditionsAbdominal Aortic AneurysmThoracoabdominal Aortic AneurysmAortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBeth Israel Deaconess Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

220 Participants
are divided into 5 treatment groups
Group A: Complex abdominal aortic aneurysm (AAA)Experimental treatment 1 intervention
Group B: Thoracoabdominal aortic aneurysm (TAAA)Experimental treatment 1 intervention
Group C: Type B aortic dissectionExperimental treatment 1 intervention
Group D: Expanded Selection ArmExperimental treatment 1 intervention
Group E: Expanded TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Perioperative mortality

Rate of death

Time frame
Up to 30-days after surgery
2

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

Time frame
Up to 30-days after surgery
3

All-cause mortality

Rate of death due to any cause at: 30-days, 6-months, 1-year, and annually to 5-years

Time frame
30-days to 5-years
4

Aneurysm-related mortality

Rate of aneurysm-related death at: 30-days, 6-months, 1-year, and annually to 5-years

Time frame
30-days to 5-years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Source ClinicalTrials.gov
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