AngioSafe Device for Peripheral Artery Disease
(RESTOR-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new system called the AngioSafe Peripheral CTO Crossing System. The researchers aim to determine if this system safely and effectively guides wires through blocked arteries in the legs, a common issue for individuals with peripheral artery disease (a condition where arteries in the legs are narrowed or blocked). Ideal candidates for this trial have been diagnosed with peripheral artery disease and have confirmed artery blockages through imaging tests like CT scans or MRIs. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiplatelet, anticoagulant, or thrombolytic therapy, and it's contraindicated, you may not be eligible to participate.
What prior data suggests that the AngioSafe Peripheral CTO Crossing System is safe?
Research has shown that the AngioSafe Peripheral CTO Crossing System is under careful study to ensure its safety for people. This device guides wires through blocked blood vessels in the legs. The main goal of these studies is to determine the device's effectiveness and safety.
Exact numbers on side effects are not yet available, as the study is in an early stage and still collecting safety information. Testing a device at this stage usually indicates some confidence in its safety, but more data is needed.
For those considering joining a trial with this system, it may be reassuring to know that similar devices have been used safely in other situations. However, discussing all potential risks and benefits with doctors is crucial.12345Why are researchers excited about this trial?
The AngioSafe Peripheral CTO Crossing System is unique because it aims to improve the way guidewires are placed beyond Chronic Total Occlusions (CTOs) in peripheral arteries. Unlike traditional treatments that may rely on more invasive procedures or struggle with difficult blockages, this system facilitates a less intrusive approach by enhancing the precision of guidewire placement. Researchers are excited about this technique because it could potentially reduce procedure time, improve success rates, and lead to better outcomes for patients with peripheral artery disease.
What evidence suggests that the AngioSafe Peripheral CTO Crossing System is effective for facilitating guidewire placement beyond CTOs?
Research has shown that the AngioSafe Peripheral CTO Crossing System, used by participants in this trial, helps doctors treat blocked blood vessels more effectively. It targets chronic total occlusions (CTOs), which are long-term blockages in blood vessels. This system assists doctors in guiding wires through these blockages more easily, leading to better treatment outcomes. Early studies indicate that the system is safe and can successfully navigate these challenging blockages. This new approach could enhance procedures for many patients with peripheral artery disease.12456
Who Is on the Research Team?
Subhash Banerjee, MD
Principal Investigator
North Texas Veterans Healthcare System
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
Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AngioSafe Peripheral CTO Crossing System
Find a Clinic Near You
Who Is Running the Clinical Trial?
AngioSafe, Inc.
Lead Sponsor
Veranex, Inc.
Collaborator