NCT05358353

A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: ReFlow Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	Bare Temporary Spur Stent System	Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.

Timeline

• Start date: 2022-10-18
• Primary completion: 2024-05-15
• Completion: 2025-05-23
• First posted: 2022-05-03
• Last updated: 2025-09-05
• Results posted: 2025-09-05

Locations

48 sites across 1 country: United States

Regulatory

• FDA-regulated device study