Can a temporary stent keep leg arteries open?

NCT ID NCT03807531

Ongoing Disease control Sponsor: ReFlow Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial is testing a temporary stent system designed to open blocked arteries below the knee in people with peripheral arterial disease. The stent is used along with a drug-coated balloon to help keep the vessel open. The study will check how well the treated arteries stay open and whether the procedure is safe over a year. Participants are adults with leg pain or wounds due to poor blood flow.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Temporary Spur Stent System (a device used with a drug-coated balloon to open blocked arteries in the lower leg)
What this could lead to: If it works, this could offer a new way to treat blocked arteries below the knee, potentially reducing the need for repeat procedures and improving blood flow in people with peripheral arterial disease.
What could go wrong: This is an early, non-randomized study with a small number of participants, so results may not apply broadly. Risks include device-related complications, vessel recoil, or the need for repeat treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for PERIPHERAL ARTERIAL DISEASE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PERIPHERAL ARTERIAL DISEASE

Contacts and locations

Locations

Auckland City Hospital

Auckland, 1023, New Zealand
Klinikum Hochsauerland Klinik für Angiologie

Arnsberg, Germany
Ospedale di Lugano Civico

Lugano, Switzerland
RoMed Klinikum Rosenheim

Rosenheim, Germany
Universitats Herzzentrum Bad Krozingen

Bad Krozingen, Germany
Universitätsklinikum Leipzig

Leipzig, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.