Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT03686306
Eligibility Criteria:
Inclusion Criteria:
1. Patient ≥ 18 years old;
2. with peripheral artery disease (ABI ≤ 0.90 or TBI ≤ 0.70 or post-exercise ABI decrease of 18.5% from rest or ABI Exercise TcPO2 with DROPmin ≤ - 15 mmHg) reporting stable limiting claudication despite optimal medical treatment (Antiplatelet / Direct Oral Anticoagulant + Lipid Lowering Drugs + AT2 antagonists / ACE Inhibitors; unless contra-indication) and advice to walk for at least 4 weeks;
3. with a walking capacity lower or equal to 500 meters on treadmill;
4. affiliation to a social security agency
5. Patient who has understood the protocol and signed the consent form to participate.
Exclusion Criteria:
1. Revascularization already decided and scheduled;
2. Critical limb ischemia;
3. Life threatening disease;
4. Contraindication related to Sildenafil:
* Patients treated with nitrates or drugs interfering with the action of sildenafil
* Ongoing treatment by Ritonavir or alpha-blockers
* Hypersensitivity to sildenafil or any of the excipients (lactose monohydrate)
* Recent history of myocardial infarction or stroke \< 3 months
* Severe cardiovascular disorders such as unstable angina, severe cardiac failure and cardiomyopathy
* Hypotension (Blood pressure \< 90/50 mmHg)
* Severe renal or hepatic failure
* Amblyopia
* Loss of vision in one eye because of Non-arterial ischemic Ophtalmic Neuropathy (NAION)
* Known hereditary degenerative retinal disorders such as retinitis pigmentosa
* Leukemia, Drepanocytosis, Multiple Myeloma
5. Pregnancy or breastfeeding;
6. Subjects under reinforced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social care establishment for purposes other than research;
7. Being in an exclusion period for another clinical study or in an ongoing interventional clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03686306
Study Brief:
Protocol Section:
NCT03686306