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Device

AngioSafe Peripheral CTO Crossing System for Peripheral Arterial Disease (RESTOR-1 Trial)

N/A
Waitlist Available
Led By Subhash Banerjee, MD
Research Sponsored by AngioSafe, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Peripheral Artery Disease
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Success of AngioSafe Peripheral CTO Crossing System
Secondary study objectives
Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).
Procedural Success of AngioSafe Peripheral CTO Crossing System
Technical Success of AngioSafe Peripheral CTO Crossing System
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AngioSafe Peripheral CTO Crossing System
2021
N/A
~140

Find a Location

Who is running the clinical trial?

AngioSafe, Inc.Lead Sponsor
Veranex, Inc.UNKNOWN
Subhash Banerjee, MDPrincipal InvestigatorNorth Texas Veterans Healthcare System
18 Previous Clinical Trials
4,018,364 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
14,253 Patients Enrolled for Peripheral Arterial Disease
~28 spots leftby Nov 2025
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