Combined Management in ALI ( Image Guided Thrombectomy With Open Transfemoral Access )
Primary Purpose
Limb Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thrombectomy and PTA
Sponsored by

About this trial
This is an interventional treatment trial for Limb Ischemia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
acute lower limb ischemia patients
Arm Description
patients with no palpable pulsations or audible signals in the lower limb
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04622878
First Posted
September 27, 2020
Last Updated
November 10, 2020
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04622878
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acute lower limb ischemia patients
Arm Type
Other
Arm Description
patients with no palpable pulsations or audible signals in the lower limb
Intervention Type
Procedure
Intervention Name(s)
thrombectomy and PTA
Intervention Description
open femoral access with fogarty catheter then PTA with balloon and possible stenting if needed
Primary Outcome Measure Information:
Title
limb salvage
Description
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
Time Frame
immediately post operative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kerolos Raafat khalil Gad Basta, resident
Phone
00201223548723
Email
kerolosbasta93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed khairy, lecturer
Phone
00201016893301
Email
Ahmedkhairy1510@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9308598
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. Erratum In: J Vasc Surg 2001 Apr;33(4):805.
Results Reference
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PubMed Identifier
21050699
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.
Results Reference
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Combined Management in ALI ( Image Guided Thrombectomy With Open Transfemoral Access )
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