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FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW

NCT06492733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-12-11

No results posted yet for this study

Summary

This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)

Conditions

  • Chronic Total Occlusion of Artery of the Extremities

Interventions

DEVICE

FastWire System - Peripheral

The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.

Sponsors & Collaborators

  • Versono Medical Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2026-05-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06492733 on ClinicalTrials.gov