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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)

NCT05358353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-05

Study results available
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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

DEVICE

Bare Temporary Spur Stent System

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

Sponsors & Collaborators

  • ReFlow Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2024-05-15
Completion
2025-05-23
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 NCT05358353 on ClinicalTrials.gov