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Device
AngioSafe Peripheral CTO Crossing System for Peripheral Arterial Disease (RESTOR-1 Trial)
N/A
Recruiting
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 procedure
Awards & highlights
RESTOR-1 Trial Summary
This trial will test a new device to see if it is safe and effective at treating blocked arteries.
Eligible Conditions
- Peripheral Arterial Disease
- Peripheral Artery Disease
RESTOR-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Success is defined as Technical Success in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.
Secondary outcome measures
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 moreRESTOR-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: AngioSafe Peripheral CTO Crossing System ProcedureExperimental Treatment1 Intervention
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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
4,018,411 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
14,253 Patients Enrolled for Peripheral Arterial Disease
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