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VIRTUOSE: Efficiency of sildenafil on the absolute claudication distance of peripheral arterial disease patients with intermittent claudication. A phase III, National, Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled trial.
EU CTIS ID: 2024-516429-30-00
What this study is testing
To determine whether sildenafil, compared with placebo, improve the walking capacity at week 24 of patients with intermittent claudication
- 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
- 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 mm Hg) 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
You likely can't join if
- Revascularization already decided and scheduled
- Critical limb ischemia
- Life threatening disease
- 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
- 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
See the full eligibility criteria
- 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 mm Hg) 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
- Revascularization already decided and scheduled
- Critical limb ischemia
- Life threatening disease
- 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
- 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
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, 65+ years, 18-64 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.