133 Participants Needed

AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

(RESTOR-1 Trial)

Recruiting at 17 trial locations
MT
Overseen ByMallik Thatipelli, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research on similar treatments, like the CROSSER system, shows that using high-frequency vibrations can successfully treat challenging blockages in blood vessels. This suggests that the AngioSafe Peripheral CTO Crossing System might also be effective in treating similar conditions.12345

Research Team

SB

Subhash Banerjee, MD

Principal Investigator

North Texas Veterans Healthcare System

Eligibility Criteria

Inclusion Criteria

Able and willing to comply with protocol requirements and sign informed consent form
Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5)
Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA))
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature

Procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
1 visit (in-person)

Treatment Details

Interventions

  • AngioSafe Peripheral CTO Crossing System
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AngioSafe Peripheral CTO Crossing System ProcedureExperimental Treatment1 Intervention
Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AngioSafe, Inc.

Lead Sponsor

Trials
2
Recruited
150+

Veranex, Inc.

Collaborator

Trials
1
Recruited
130+

References

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial. [2021]
Best crossing of peripheral chronic total occlusions. [2023]
Endovascular treatment of infrainguinal chronic total occlusions using the TruePath device: features, handling, and 6-month outcomes. [2014]
Use of high-frequency vibrational energy in the treatment of peripheral chronic total occlusions. [2016]
Crossing Algorithm for Infrainguinal Chronic Total Occlusions: An Interdisciplinary Expert Opinion Statement. [2023]