FREEFLOW Study for Chronic Total Occlusion of Extremities
This study is testing a device called the FastWire System to see if it can safely and effectively help doctors treat blockages in leg arteries. These blockages are called chronic total occlusions (CTOs) and can cause pain or serious limb problems. The FastWire System helps guide other tools past these blockages. We want to see if the FastWire System works well during the procedure and if it causes any serious problems within 30 days. You might be able to join if you are 18 to 85 years old and have severe leg pain when walking (claudication) or a more serious limb condition (critical limb ischemia). The current status of the study is unclear.
- Study design
- This is a single-arm study, meaning everyone receives the FastWire System. It plans to enroll up to 65 participants across multiple centers.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be checked for up to 30 days after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
At a glance
Conditions
Where it's being run
6 sites across 6 statesWho to contact
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What this trial measures
- Clinical success (On Day of Procedure)Day 1
Ability to facilitate treatment of the target lesion using the FastWire as a crossing device only and by allowing additional devices to cross the CTO as required. This will be angiographically confirmed.
- Freedom from Serious Adverse EventsUp to Day 30
Freedom from Serious Adverse Events related to the use of the FastWire System, at 30 days post procedure: * Cardiovascular deaths. * Vessel dissection (Grade C or greater) requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization is defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure and requiring mechanical or pharmacologic means to improve flow.