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

NCT04622878 | Unknown

• 1 other identifier: Combined Management in ALI
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

acute lower limb ischemia patients

OTHER

patients with no palpable pulsations or audible signals in the lower limb

Procedure: thrombectomy and PTA

Interventions

thrombectomy and PTA PROCEDURE

open femoral access with fogarty catheter then PTA with balloon and possible stenting if needed

acute lower limb ischemia patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 9308598 BACKGROUND

• 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.

  PMID: 21050699 BACKGROUND

MeSH Terms

Interventions

Thrombectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

kerolos Raafat khalil Gad Basta, resident

CONTACT

00201223548723; kerolosbasta93@gmail.com

Ahmed khairy, lecturer

CONTACT

00201016893301; Ahmedkhairy1510@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician at vascular surgery department ، Assiut University

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: November 10, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11