Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746677
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2021-01-28
Brief Title:
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts PMEGs
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects aortic pathology 1 Complex abdominal aortic aneurysm AAA 2 Thoracoabdominal aortic aneurysm and 3 Aortic dissection
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 andor 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 surgicalanatomical 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 FB-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 patients 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
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 FB-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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None