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Study of Peripheral Arterial Calcification

Primary Purpose

PAD

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular therapy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for PAD

Eligibility Criteria

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

Inclusion Criteria:

  1. patients with peripheral arterial disease
  2. patients with disabling limb claudication
  3. patients with rest pain
  4. patients with minor tissue loss
  5. patients admitted to vascular surgery department for endovascular intervention of a denovo lower limb arterial lesion

Exclusion Criteria:

  • 1)Patient's age less than 50. 2)Patients with major tissue loss [ Rutherford category 6] 3)Patients with recurrent lesion after previous intervention. 4)Patients with double level arterial lesion. 5) Patients refusing to participate in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Endovascular therapy

    Arm Description

    Outcome of endovascular therapy on PAC

    Outcomes

    Primary Outcome Measures

    Primary patency
    which means maintaining vessel patency without restenosis or need for re-intervention.
    Major adverse limb events (MALE):
    by which we mean repeated endovascular therapy, surgical revision, or major amputation during follow up period.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2019
    Last Updated
    September 26, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04108806
    Brief Title
    Study of Peripheral Arterial Calcification
    Official Title
    Study of Peripheral Arterial Calcification as a Possible Predictor of Outcome After Endovascular Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 27, 2019 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 27, 2020 (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
    Aim of the work : 1. Using different calcification scoring systems to investigate the association between arterial calcification and clinical outcome following endovascular therapy
    Detailed Description
    Peripheral arterial disease (PAD) is a worldwide health problem and its prevalence is increasing among aging population. Symptomatic PAD Is a major cause of major amputation with reduction of the functional capacity and quality of life . Arterial calcification is calcium crystallization deposits in the extracellular matrix of the intima and media . Medial calcification is usually associated with chronic kidney disease and diabetes mellitus, while intimal calcification comes usually as a part of atherosclerotic process . The relationship between calcification and PAD is well established . Arterial calcification is associated with increased risk of procedural failure and major amputation . Many calcium scoring systems have been proposed, including peripheral arterial calcium scoring scale (PACSS which highlights the pathologic location of calcification along with the length of the segment affected. The peripheral academic research consortium (PARC) suggested another calcium scoring scale that classified calcification into 4 major grades . The DEFENETIVE Ca++ have proposed another calcium severity scoring . Intravascular Ultrasound (IVUS) is highly sensitive to presence and location of atherosclerotic calcium . The impact of intimal and medial vascular calcification on the safety and effectiveness of endovascular devices to treat symptomatic peripheral arterial disease (PAD) remains poorly defined warranting continued research to elaborate relationship between calcification and endovascular outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PAD

    7. Study Design

    Primary Purpose
    Diagnostic
    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
    Endovascular therapy
    Arm Type
    Experimental
    Arm Description
    Outcome of endovascular therapy on PAC
    Intervention Type
    Procedure
    Intervention Name(s)
    Endovascular therapy
    Intervention Description
    Ballon dialtation of the diseased artery
    Primary Outcome Measure Information:
    Title
    Primary patency
    Description
    which means maintaining vessel patency without restenosis or need for re-intervention.
    Time Frame
    1 year
    Title
    Major adverse limb events (MALE):
    Description
    by which we mean repeated endovascular therapy, surgical revision, or major amputation during follow up period.
    Time Frame
    1year

    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: patients with peripheral arterial disease patients with disabling limb claudication patients with rest pain patients with minor tissue loss patients admitted to vascular surgery department for endovascular intervention of a denovo lower limb arterial lesion Exclusion Criteria: 1)Patient's age less than 50. 2)Patients with major tissue loss [ Rutherford category 6] 3)Patients with recurrent lesion after previous intervention. 4)Patients with double level arterial lesion. 5) Patients refusing to participate in this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hazem Mohamed
    Phone
    01140210730
    Email
    Hazemzaki57@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Bakr
    Phone
    01204510848
    Email
    ahmedhassan.bakr@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesham Elsayed
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ayman Sayed
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/22107687/
    Description
    Related Info

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    Study of Peripheral Arterial Calcification

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