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Device
AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study) (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
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 moreAwards & 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