Study of Peripheral Arterial Calcification

Study of Peripheral Arterial Calcification as a Possible Predictor of Outcome After Endovascular Therapy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04108806

Enrollment

100

Registered

2019-09-30

Start date

2019-09-27

Completion date

2020-09-27

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PAD

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.

Interventions

PROCEDUREEndovascular therapy

Ballon dialtation of the diseased artery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Primary patency	1 year	which means maintaining vessel patency without restenosis or need for re-intervention.
Major adverse limb events (MALE):	1year	by which we mean repeated endovascular therapy, surgical revision, or major amputation during follow up period.

Contacts

Primary ContactHazem Mohamed

Hazemzaki57@yahoo.com01140210730

Backup ContactAhmed Bakr

ahmedhassan.bakr@gmail.com01204510848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026