NCT04663867

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

Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: AngioSafe, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.

Conditions

• Peripheral Artery Occlusion
• Peripheral Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-03
• Primary completion: 2023-04-25
• Completion: 2023-06-15
• First posted: 2020-12-11
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study