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Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

Primary Purpose

Critical Limb Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retrograde access for re-canalization of infra-inguinal arterial occlusive disease
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

35 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with;

  1. CLI consistent with Rutherford categories (4-5).
  2. Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.

Exclusion Criteria:

patients with the following conditions will be excluded:

  1. Non-salvageable limbs.
  2. Life threatening infections requiring major amputation.
  3. Ulcers at the area of intended puncture.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    patients with infrainguinal arterial occlusive disease after failed antegrade approach

    Arm Description

    Outcomes

    Primary Outcome Measures

    safety of retrograde approach as regard occurrence of procedure specific complications
    safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
    feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
    it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success. successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site. technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.

    Secondary Outcome Measures

    clinical success of the procedure
    immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.
    One year limb salvage rate of the procedure
    limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.

    Full Information

    First Posted
    July 13, 2021
    Last Updated
    July 15, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04974905
    Brief Title
    Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
    Official Title
    Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    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 spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption. Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene. Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization. Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical 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
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with infrainguinal arterial occlusive disease after failed antegrade approach
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    retrograde access for re-canalization of infra-inguinal arterial occlusive disease
    Intervention Description
    after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted
    Primary Outcome Measure Information:
    Title
    safety of retrograde approach as regard occurrence of procedure specific complications
    Description
    safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
    Time Frame
    within one year of follow up
    Title
    feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
    Description
    it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success. successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site. technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.
    Time Frame
    within one year of follow up
    Secondary Outcome Measure Information:
    Title
    clinical success of the procedure
    Description
    immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.
    Time Frame
    within one year of follow up
    Title
    One year limb salvage rate of the procedure
    Description
    limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.
    Time Frame
    within one year of follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with; CLI consistent with Rutherford categories (4-5). Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot. Exclusion Criteria: patients with the following conditions will be excluded: Non-salvageable limbs. Life threatening infections requiring major amputation. Ulcers at the area of intended puncture.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa A Foda, Msc
    Phone
    01012514518
    Email
    m_foda_revolution2020@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hussein K Hussein, Professor
    Phone
    01222142667

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31834669
    Citation
    Mustapha JA, Saab F, McGoff TN, Adams G, Mullins JR, Al-Dadah A, Jaff MR, Goodney PP, Khawaja F, Diaz-Sandoval LJ. Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME). Catheter Cardiovasc Interv. 2020 Feb 15;95(3):447-454. doi: 10.1002/ccd.28639. Epub 2019 Dec 13.
    Results Reference
    background
    PubMed Identifier
    25241321
    Citation
    Hendricks NJ, Sabri SS. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) and rertograde access for critical limb ischemia. Tech Vasc Interv Radiol. 2014 Sep;17(3):203-10. doi: 10.1053/j.tvir.2014.08.009. Epub 2014 Sep 4.
    Results Reference
    background
    PubMed Identifier
    24650744
    Citation
    Bazan HA, Le L, Donovan M, Sidhom T, Smith TA, Sternbergh WC 3rd. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014 Aug;60(2):375-81. doi: 10.1016/j.jvs.2014.02.038. Epub 2014 Mar 18.
    Results Reference
    background

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    Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

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