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

NCT04663867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-02-12

Study results available
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Summary

The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.

Conditions

  • Peripheral Artery Occlusion
  • Peripheral Arterial Disease

Interventions

DEVICE

AngioSafe Peripheral CTO Crossing System

The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.

Sponsors & Collaborators

  • Veranex, Inc.

    collaborator UNKNOWN

  • AngioSafe, Inc.

    lead INDUSTRY

Principal Investigators

  • Subhash Banerjee, MD · North Texas Veterans Healthcare System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2023-04-25
Completion
2023-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04663867 on ClinicalTrials.gov