Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03159858
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-05-19
First Post:
2017-05-17
Brief Title:
Compassionate Use Treatment for a Single Patient With a Custom Made BranchedFenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Compassionate Use Treatment for a Single Patient With a Custom Made BranchedFenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE HL-B ONE-SHOT INTRODUCTION SYSTEM is neither commercially available or available as part of a clinical trial IRB approval of this protocol was requested so that Cook Incorporated may apply to the FDA for approval for one-time use of this patient-specific device for compassionate use for patient AO It is a custom made endovascular device consisting of4 fenestrations for the celiac SMA superior mesenteric and left and right renal arteries
Detailed Description:
The Custom Made BranchedFenestrated Endovascular Device to be used in this treatment plan is not Food and Drug Administration FDA-approved and is approved for use only in a clinical study However the FDA has allowed the use of this device for compassionate use
The devices used are tubular grafts made of polyester fabric sewn to metal stents The upper part of the grafts includes fenestrations holes that allow the grafts to be located above or near major arteries that branch off of the aorta celiac artery superior mesenteric artery SMA and renal arteries without blocking blood flow to them The celiac artery supplies blood to internal organs including the liver and stomach The SMA supplies blood to internal organs as well including parts of the large and small intestines The renal arteries supply blood to the kidneys Grafts with branches andor fenestrations are needed when the aneurysm is located near these major arteries The major arteries that branch off of the aorta celiac artery SMA and renal arteries may also be treated using stents small tubular metal structures to help keep the arteries open and aligned with the graft fenestrations holes
The devices used are tubular grafts made of polyester fabric sewn to metal stents The upper part of the grafts includes fenestrations holes that allow the grafts to be located above or near major arteries that branch off of the aorta celiac artery superior mesenteric artery SMA and renal arteries without blocking blood flow to them The celiac artery supplies blood to internal organs including the liver and stomach The SMA supplies blood to internal organs as well including parts of the large and small intestines The renal arteries supply blood to the kidneys Grafts with branches andor fenestrations are needed when the aneurysm is located near these major arteries The major arteries that branch off of the aorta celiac artery SMA and renal arteries may also be treated using stents small tubular metal structures to help keep the arteries open and aligned with the graft fenestrations holes
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