The assessment of cysteinyl leukotriene receptor antagonist role in inhibition of atherosclerosis, proliferation and its influence on endothelial function in patients undergoing endovascular treatment due to peripheral arterial disease.

Phase 1

• Conditions: Ischemia of the lower limbs in the course of obstructive artery disease; MedDRA version: 21.1Level: LLTClassification code: 10067825Term: Peripheral arterial disease Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-511894-32-00
• Lead Sponsor: niwersytet Jagiellonski Collegium Medicum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients with PAOD qualified for PTAvin the Angiology Department UJ CM, with Rutherford 3 or 4 clinical symptoms., Age 45 - 75 years old., Signed informed consent., Citizen of Malopolska region

Exclusion Criteria

Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms., Buerger Disease., Chronic heart failure (3-4 NYHA), Acute lower limb ischemia or surgical revascularization within last 6 months., Serious trauma or surgery procedure within last 6 months., Asthma., Ongoing antileukotriene treatment, Neoplasm diagnosed within 5 years., Chronic Kidney Disease (creat. >177 µmol/l)., Pregnancy, puerperium, women without efficient contraception., Vaccinations within 30 days before recruitment., Age < 45 or > 75 years old., Hospitalisation in intensive care unit within 3 months., Lack of the possibility of the follow-up participation., Infection and/or fever (temperature above 37,2 C) within the last 3 weeks preceding the study recruitment (viral infections, cold, sinusitis) and use of antibiotics within the last 2 months., Symptoms of acute tissue infection, Chronic inflammatory disease (e.g. COPD stage >II in GOLD classification), HIV+, HCV+, HBS+., Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months., Inflammatory blood vessel disorders (with exception of atherosclerosis), Myocardial infarction or stoke within last 6 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main goal of this study is to investigate the influence of the use of cysteinyl leukotrienes receptor antagonists on lower limbs arteries reocclusion rate in patients with peripheral artery occlusive disease (PAOD) after endovascular treatment.;Secondary Objective: Assessment of the improvement in the quality of life patients treated endovascularly for ischemia of the lower limbs caused by the use of a leukotriene receptor antagonist (montelukast).;Primary end point(s): Restenosis in a previously treated artery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):MACE, high lower limb amputation, significant loss in quality of life