Montelukast for Peripheral arterial disease | Lower limb ischemia

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Restenosis in a previously treated artery","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- MACE, high lower limb amputation, significant loss in quality of life","definition_or_measurement_approach":""}

Poland

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

01-07-2024

Processing Time Days

27

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Uniwersytet Jagiellonski Collegium Medicum

Organisation Type

Educational Institution

Country Of Registered Address

Poland