CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled / 130 target
Drug / intervention
Bare Temporary Spur Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05358353
NCT05358353N/ACompletedMonitor (2.9/mo)Completion was 25mo ago
CompareCT.gov

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)

ReFlow Medical, Inc.·interventional·Posted May 3, 2022·Updated Jun 2, 2026

In Brief

A clinical study evaluating Bare Temporary Spur Stent System for Peripheral Arterial Disease and Critical Limb Ischemia. Completed, enrolled 130 participants across 48 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Critical Limb Ischemia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 3, 2022
Enrollment StartOct 18, 2022
Primary CompletionMay 15, 2024
Study CompletionMay 23, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.2 years ago

Arms & Interventions

Bare Temporary Spur Stent Systemexperimental

Treatment with the Temporary Bare Spur Stent System (Spur Stent System).

Device: Bare Temporary Spur Stent System

Interventions

Bare Temporary Spur Stent Systemdevice

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