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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limb Ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 27, 2020
    Last Updated
    November 10, 2020
    Sponsor
    Assiut University
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    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
    background
    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
    background

    Learn more about this trial

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

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