Ignite Creation Date:
2024-05-06 @ 2:42 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02101463
Status:
TERMINATED
Last Update Posted:
2019-11-15
First Post:
2014-03-25
Brief Title:
MOSTEGRA TRIALMO-Dified STE-nt GRA-ft Surgeon-modified Fenestrated-branched Stent-grafts
Sponsor:
Northside Hospital Inc
Organization:
Northside Hospital Inc
Study Overview
Official Title:
Surgeon-Modified FenestratedBranched Stent-Grafts for Treatment of Complex Aortic Aneurysms in High-Risk Patients
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator left the organization and took the IDEStudy with him
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOSTEGRA
Brief Summary:
This trial evaluates surgeon-modified fenestrated-branched stent-grafts sm-FBSG for Abdominal Aortic Aneurysms AAA that are custom-made intra-operatively with no waiting period by a qualified vascular surgeon In addition it aims to examine the alternative sm-FBSG for patients with restricted access to centers performing clinical trials with commercially available devices and those patients with aortic emergencies
Detailed Description:
Complex aortic aneurysms are those involving the renal and visceral arteries and open repair of these aneurysms requires more extensive dissection aortic clamping above the renal or mesenteric arteries and possible reconstruction of aortic branches Recovery time tends to be longer including more hospital days than for endovascular repair and there is a greater potential for complications Many high-risk patients with aneurysms of the abdominal aorta AAA including thoracoabdominal aortic aneurysms TAAA and significant co-morbidities will be denied elective open surgery because of heightened risks associated with open repair of complex aneurysms and therefore the potential benefit of an endovascular option increases as well
Endovascular aneurysm repair has been shown to be an effective alternative in treating uncomplicated infrarenal and thoracic aneurysms in both the elective and urgent setting yet there is limited experience with this technology in complex conditions Fenestrated grafts have been developed as a minimally invasive treatment for patients with complex aortic aneurysms who are unfit for traditional open surgery
Surgeon-modified fenestrated-branch stent grafts sm-FBSG with branches for the visceral vessels are custom-made by a qualified vascular surgeon for patients with complex aortic conditions It is expected that they will minimize surgical risks and promote quicker recovery and they could represent a therapeutic option for high-risk patients unfit for open surgery
Endovascular aneurysm repair has been shown to be an effective alternative in treating uncomplicated infrarenal and thoracic aneurysms in both the elective and urgent setting yet there is limited experience with this technology in complex conditions Fenestrated grafts have been developed as a minimally invasive treatment for patients with complex aortic aneurysms who are unfit for traditional open surgery
Surgeon-modified fenestrated-branch stent grafts sm-FBSG with branches for the visceral vessels are custom-made by a qualified vascular surgeon for patients with complex aortic conditions It is expected that they will minimize surgical risks and promote quicker recovery and they could represent a therapeutic option for high-risk patients unfit for open surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None