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Study of Peripheral Arterial Calcification

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04108806
Collaborator
(none)
100
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

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
Condition or Disease Intervention/Treatment Phase
  • Procedure: Endovascular therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of Peripheral Arterial Calcification as a Possible Predictor of Outcome After Endovascular Therapy
Anticipated Study Start Date :
Sep 27, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endovascular therapy

Outcome of endovascular therapy on PAC

Procedure: Endovascular therapy
Ballon dialtation of the diseased artery

Outcome Measures

Primary Outcome Measures

  1. Primary patency [1 year]

    which means maintaining vessel patency without restenosis or need for re-intervention.

  2. Major adverse limb events (MALE): [1year]

    by which we mean repeated endovascular therapy, surgical revision, or major amputation during follow up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Hesham Elsayed, Assiut University
  • Principal Investigator: Ayman Sayed, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
hazem mohamed zaki mohamed, Resident of vascular surgery, Assiut University
ClinicalTrials.gov Identifier:
NCT04108806
Other Study ID Numbers:
  • Endovascular therapy in PAC
First Posted:
Sep 30, 2019
Last Update Posted:
Sep 30, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Calcinosis

Study Results

No Results Posted as of Sep 30, 2019