Clinical trial NCT04108806: Study of Peripheral Arterial Calcification
Official title: Study of Peripheral Arterial Calcification as a Possible Predictor of Outcome After Endovascular Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PAD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary patency
timeFrame: 1 year
measure: Major adverse limb events (MALE):
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hesham Elsayed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ayman Sayed
role: PRINCIPAL_INVESTIGATOR
References: