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

(RESTOR-1 Trial)

Recruiting at 17 trial locations

Overseen By Mallik Thatipelli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AngioSafe, Inc.

Must not be taking: Antiplatelets, Anticoagulants, Thrombolytics

Disqualifiers: Systemic infection, Stroke, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Procedure

133 Participants Needed

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. ^{1 2 3 4 5}

Research Team

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))

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

Group I: AngioSafe Peripheral CTO Crossing System Procedure Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AngioSafe, Inc.

Lead Sponsor

Trials

2

Recruited

150+

Veranex, Inc.

Collaborator

Trials

1

Recruited

130+

References

1. United States pubmed.ncbi.nlm.nih.gov

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Best crossing of peripheral chronic total occlusions. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Endovascular treatment of infrainguinal chronic total occlusions using the TruePath device: features, handling, and 6-month outcomes. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Use of high-frequency vibrational energy in the treatment of peripheral chronic total occlusions. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Crossing Algorithm for Infrainguinal Chronic Total Occlusions: An Interdisciplinary Expert Opinion Statement. [2023]