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

Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04622878
• Other study ID #: Combined Management in ALI
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: kerolos Raafat khalil Gad Basta, resident
• Phone: 00201223548723
• Email: kerolosbasta93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Limb Ischemia

Intervention

Procedure:
• thrombectomy and PTA
open femoral access with fogarty catheter then PTA with balloon and possible stenting if needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View 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. Erratum in: J Vasc Surg 2001 Apr;33(4):805. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	limb salvage	Technical success rates is defined as patency of the treated vessel segment with less than 20 % residual stenosis , without dissection and restoration of in line flow to foot , weight and height of the pt will be combined to report BMI kg/m^2	immediately post operative