FastWire System for Peripheral Vascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the FastWire System to determine its safety and effectiveness in placing medical devices in patients with blocked leg arteries. It targets individuals with severe leg pain when walking (claudication) or critical limb-threatening ischemia (CLTI). Suitable candidates have a total blockage in a leg artery below the knee and experience severe walking pain or related leg issues. Participants should not have had recent heart attacks or strokes and should not have undergone previous treatments on the blocked artery. As an unphased trial, this study allows patients to contribute to innovative research that could enhance treatment options for severe leg artery blockages.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the FastWire System is safe for peripheral vascular disease?
Research on the FastWire System shows it helps doctors place guidewires past arterial blockages, crucial for treating peripheral artery disease, where blood flow is limited.
Specific safety data for the FastWire System from earlier studies is unavailable. However, its "Not Applicable" phase suggests ongoing testing for basic functions and initial safety.
Typically, reaching this stage means initial tests have shown reasonable safety for further testing. If the FastWire System resembles the FastWave Artero™ IVL System, used for similar conditions, some evidence suggests it may be safe and effective.
Prospective trial participants should discuss potential risks and benefits with the trial team. They will provide the most current information on the FastWire System's tolerance and any side effects reported in ongoing studies.12345Why are researchers excited about this trial?
Researchers are excited about the FastWire System because it offers a unique approach to treating peripheral vascular disease. Unlike traditional methods that often struggle with chronic total occlusions (CTOs) in the arteries, the FastWire System is specifically designed to help guide conventional devices and wires beyond these blockages. This could potentially make procedures quicker and less invasive, improving outcomes for patients with peripheral artery disease.
What evidence suggests that the FastWire System is effective for peripheral vascular disease?
Research shows that the FastWire System, which participants in this trial will receive, holds promise for treating peripheral vascular disease, particularly in completely blocked arteries. Studies have found it effective at navigating severely blocked areas in leg arteries, such as those in the lower leg and thigh. This capability helps doctors place other treatment tools more easily and accurately. Early reports suggest that using FastWire can shorten procedure time and improve treatment outcomes for patients with peripheral artery disease (PAD). These findings support the idea that FastWire could be a valuable tool for managing difficult artery blockages.12345
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the FastWire procedure to facilitate treatment of the target lesion using the FastWire as a crossing device
Follow-up
Participants are monitored for safety and effectiveness, including freedom from serious adverse events and procedure-related outcomes
What Are the Treatments Tested in This Trial?
Interventions
- FastWire System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Versono Medical Ltd
Lead Sponsor
Citations
Study Details | NCT06492733 | FastWire REvascularisation ...
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal ...
NCT07209085 | A Study to Evaluate the Safety and ...
The results will help determine if the FastWave Artero™ IVL System can be used as a safe and effective treatment for people with PAD and severe ...
3.
ctv.veeva.com
ctv.veeva.com/study/fastwire-revascularisation-of-extremities-for-lower-limbs-feasibility-study-freeflowFastWire REvascularisation of Extremities, (For LOWer Limbs)
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the ...
4.
irishtechnews.ie
irishtechnews.ie/versono-medical-enrols-first-patients-in-pivotal-study-for-revolutionary-new-tech/Versono Medical enrols first patients in pivotal study for ...
That found FastWire to be hugely effective at crossing severely calcified long lesions in tibial and Fem Pop arteries, enabling their treatment, reducing the ...
Invasive Physiological Assessment of Lower Limb Peripheral ...
This review explores the current methods, challenges, and future directions of invasive physiological assessment in PAD.
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