Study of Peripheral Arterial Calcification

PAD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04108806
• Other study ID #: Endovascular therapy in PAC
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 27, 2020

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Hazem Mohamed
• Phone: 01140210730
• Email: Hazemzaki57[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the work :

1. Using different calcification scoring systems to investigate the association between arterial calcification and clinical outcome following endovascular therapy

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 27, 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• PAD

Intervention

Procedure:
• Endovascular therapy
Ballon dialtation of the diseased artery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

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

External Links

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