AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
(RESTOR-1 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new device that helps doctors clear blocked arteries in the legs. It aims to show that the device is safe and works well for patients with severe artery blockages. The study will include at least 70 patients and will monitor them for a short period.
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 data supports the effectiveness of the AngioSafe Peripheral CTO Crossing System treatment?
Research Team
Subhash Banerjee, MD
Principal Investigator
North Texas Veterans Healthcare System
Eligibility Criteria
Inclusion Criteria
Timeline
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
Treatment Details
Interventions
- AngioSafe Peripheral CTO Crossing System
Find a Clinic Near You
Who Is Running the Clinical Trial?
AngioSafe, Inc.
Lead Sponsor
Veranex, Inc.
Collaborator