NCT04622878

Combined Management in ALI ( Image Guided Thrombectomy With Open Transfemoral Access )

Combined Treatment ( Image Guided Thrombectomy and Endovascular Therapy With Open Femoral Access ) for Acute Limb Ischemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Conditions

• Limb Ischemia

Interventions

Type	Name	Description
PROCEDURE	thrombectomy and PTA	open femoral access with fogarty catheter then PTA with balloon and possible stenting if needed

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2020-11-10
• Last updated: 2020-11-13