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

Conditions

• Peripheral Arterial Disease
• Peripheral Artery Occlusion

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AngioSafe Peripheral CTO Crossing System — DEVICE
  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.

Study Details

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

Key Dates

First listed

Dec 11, 2020

Start date

Feb 3, 2021

Status verified

Feb 2026

Primary completion

Apr 25, 2023

Completion

Jun 15, 2023

Study Design

Enrollment

79 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Clinical Success of AngioSafe Peripheral CTO Crossing System [ Time Frame: 24 Hours ]

Locations (18)

Find similar trials in Chandler, AZ

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