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

Abdominal Aortic Aneurysm Clinical Trial

Official title: Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracoabdominal
• Aortic Dissection
• Thoracoabdominal Aortic Aneurysm

• NCT number: NCT04746677
• Study type: Interventional
• Source: Beth Israel Deaconess Medical Center
• Contact: Theresa Bishop, BSN
• Phone: 617-632-9975
• Email: tbishop@bidmc.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Completion date: December 31, 2030