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Leg-saving vein bypass shows promise for worst-case artery disease

NCT ID NCT03321552

Completed Disease control Sponsor: LimFlow SA Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new procedure called percutaneous deep vein arterialization in 34 people with critical limb ischemia, a severe form of blocked leg arteries. The procedure uses a device to create a bypass using a vein, aiming to improve blood flow and prevent amputation. The main goal was to see if it could help people avoid death or major amputation.

What this could mean

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

Active substance
LimFlow System (a device to create an arterio-venous fistula in the leg)
What this could lead to
If it works, this could offer a way to save the leg from amputation in people with severe blocked leg arteries who have no other options.
What could go wrong
This is a small, early study with only 34 people, so results may not apply to everyone. The procedure carries risks like infection, bleeding, or the fistula not staying open.

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

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

CRITICAL LIMB ISCHEMIA

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, New Zealand

  • Changi General Hospital

    Singapore, 529889, Singapore

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5200 ME, Netherlands

  • Klinikum Arnsberg GmbH

    Arnsberg, North Rhine-Westphalia, 59755, Germany

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD, Netherlands

  • SRH Klinikum Karlsbad-Langensteinbach

    Karlsbad, Baden-Wurttemberg, 76307, Germany

  • St. Antonius Hospital

    Nieuwegein, 3430 EM, Netherlands

  • St. Franziskus-Hospital GmbH

    Münster, North Rhine-Westphalia, 48145, Germany

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Universitätsklinikum Graz

    Graz, 8036, Austria

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 4103, Germany

More trials for these conditions

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