Study of Peripheral Arterial Calcification
Primary Purpose
PAD
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for PAD
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
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
NCT ID
NCT04108806
First Posted
September 25, 2019
Last Updated
September 26, 2019
Sponsor
Assiut University
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
Learn more about this trial
Study of Peripheral Arterial Calcification
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