VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

Ki vehet részt

• Patient ≥ 18 years old
• 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
• with a walking capacity lower or equal to 500 meters on treadmill
• affiliation to a social security agency
• Patient who has understood the protocol and signed the consent form to participate

Ki nem vehet részt

• 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
• Life threatening disease
• Revascularization already decided and scheduled
• Critical limb ischemia
• Pregnancy or breastfeeding
• 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
• Being in an exclusion period for another clinical study or in an ongoing interventional clinical study