Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04622878
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-09-27
Brief Title:
Combined Management in ALI Image Guided Thrombectomy With Open Transfemoral Access
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Combined Treatment Image Guided Thrombectomy and Endovascular Therapy With Open Femoral Access for Acute Limb Ischemia
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
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:
Acute limb ischemia ALI is a sudden decrease in limb perfusion due to either an embolic or a thrombotic vascular occlusion defined as the presence of symptoms within two weeks of onset The profound ischemia represents an emergency in which delayed treatment results in limb loss and potentially death Therefore timely diagnosis and proper treatments for ALI are important
Both surgical thrombectomy and endovascular treatment have benefits and drawbacks Surgical thrombectomy using Fogarty embolectomy catheter has been the standard therapy because it is rapid and effective in cases of embolic ALI However blind surgical thrombectomy can result in poor revascularization or unexpected vascular injury in the presence of underlying arterial atherosclerosis or in the presence of subacute and chronic thrombi In addition thrombosis of runoff vessels is difficult to remove
Endovascular management using catheter-directed thrombolysis CDT has emerged as an alternative to surgery It is less invasive and does not directly damage the vascular endothelium with the capacity to clear thrombus in the small vessels However long treatment duration may worsen the clinical situation Besides a thrombus of more than two weeks does not respond well to the thrombolysis and it is difficult to determine the exact stage of thrombus according to the clinical history These problems may be minimized by combined treatment which includes surgical thrombectomy and endovascular treatment
Both surgical thrombectomy and endovascular treatment have benefits and drawbacks Surgical thrombectomy using Fogarty embolectomy catheter has been the standard therapy because it is rapid and effective in cases of embolic ALI However blind surgical thrombectomy can result in poor revascularization or unexpected vascular injury in the presence of underlying arterial atherosclerosis or in the presence of subacute and chronic thrombi In addition thrombosis of runoff vessels is difficult to remove
Endovascular management using catheter-directed thrombolysis CDT has emerged as an alternative to surgery It is less invasive and does not directly damage the vascular endothelium with the capacity to clear thrombus in the small vessels However long treatment duration may worsen the clinical situation Besides a thrombus of more than two weeks does not respond well to the thrombolysis and it is difficult to determine the exact stage of thrombus according to the clinical history These problems may be minimized by combined treatment which includes surgical thrombectomy and endovascular treatment
Detailed Description:
The aim of our research is to evaluate the effectiveness and safety of combined treatment surgical thrombectomy and endovascular treatment for ALI with various clinical considerations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None