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Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

Primary Purpose

Critical Lower Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
long surgical bypass
Hybrid approach
Sponsored by
Egyptian Biomedical Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Lower Limb Ischemia

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
  • Fontaine classification stage IV (gangrene or necrosis).
  • Rutherford grade III and IV category 5 and 6 with salvageable foot

Exclusion Criteria:

  • heart failure
  • liver failure
  • renal impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    long surgical bypass

    Hybrid approach

    Arm Description

    long surgical bypass for multilevel lower limb ischemia

    surgical bypass and endovascular treatment for multilevel lower limb ischemia

    Outcomes

    Primary Outcome Measures

    Late occlusion
    Late occlusion of the affected vessels

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2020
    Last Updated
    July 24, 2020
    Sponsor
    Egyptian Biomedical Research Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04490408
    Brief Title
    Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
    Official Title
    Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 20, 2014 (Actual)
    Primary Completion Date
    April 17, 2019 (Actual)
    Study Completion Date
    April 17, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Egyptian Biomedical Research Network

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Lower Limb Ischemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    long surgical bypass
    Arm Type
    Active Comparator
    Arm Description
    long surgical bypass for multilevel lower limb ischemia
    Arm Title
    Hybrid approach
    Arm Type
    Experimental
    Arm Description
    surgical bypass and endovascular treatment for multilevel lower limb ischemia
    Intervention Type
    Procedure
    Intervention Name(s)
    long surgical bypass
    Intervention Description
    long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hybrid approach
    Intervention Description
    Hybrid approach including bypass and endovascular revascularization
    Primary Outcome Measure Information:
    Title
    Late occlusion
    Description
    Late occlusion of the affected vessels
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse. Fontaine classification stage IV (gangrene or necrosis). Rutherford grade III and IV category 5 and 6 with salvageable foot Exclusion Criteria: heart failure liver failure renal impairment

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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