Clinical trial NCT04622878: Combined Management in ALI ( Image Guided Thrombectomy With Open Transfemoral Access )
Official title: Combined Treatment ( Image Guided Thrombectomy and Endovascular Therapy With Open Femoral Access ) for Acute Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Limb Ischemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* Patients with acute onset of lower limb pain with various degrees of movement compromise.
* History of intermittent claudication with a sudden worsening of claudication and pain at rest for less than one month.
* Patients with Duplex or MSCT angiography of the lower limbs showing embolic events on healthy vessels or thrombosis of diseased vessels with or without collateralization.
* Thrombus in a poor location that is difficult to be removed by surgical thrombectomy alone.
* Acute lower limb ischemia due to acute arterial graft occlusion

Exclusion Criteria:

* - Medically compromised patients, not fit for the intervention.
* Patients with critical chronic limb ischemia (grade III, IV).
* Patients with known vasculitis or lab investigations suggesting vasculitis before treating the cause.
* Patients who refused the intervention.

Primary outcomes:
measure: limb salvage
timeFrame: immediately post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
citation: Kashyap VS, Gilani R, Bena JF, Bannazadeh M, Sarac TP. Endovascular therapy for acute limb ischemia. J Vasc Surg. 2011 Feb;53(2):340-6. doi: 10.1016/j.jvs.2010.08.064. Epub 2010 Nov 3.