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A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee

NCT03807531 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.

This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland.

At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site).

The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Temporary Spur Stent System

Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • ReFlow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Holden, MBChB · Auckland Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2023-04-30
Completion
2028-06-01

Countries

  • Germany
  • New Zealand
  • Switzerland

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 NCT03807531 on ClinicalTrials.gov