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.
EU CTIS ID: 2024-511894-32-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.