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Study of Peripheral Arterial Calcification

NCT ID: NCT04108806

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2020-09-27

Brief Summary

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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

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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.

Conditions

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PAD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endovascular therapy

Outcome of endovascular therapy on PAC

Group Type EXPERIMENTAL

Endovascular therapy

Intervention Type PROCEDURE

Ballon dialtation of the diseased artery

Interventions

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Endovascular therapy

Ballon dialtation of the diseased artery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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hazem mohamed zaki mohamed

Resident of vascular surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hesham Elsayed

Role: STUDY_DIRECTOR

Assiut University

Ayman Sayed

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Hazem Mohamed

Role: CONTACT

Phone: 01140210730

Email: [email protected]

Ahmed Bakr

Role: CONTACT

Phone: 01204510848

Email: [email protected]

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/22107687/

Related Info

Other Identifiers

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Endovascular therapy in PAC

Identifier Type: -

Identifier Source: org_study_id