Promising Leg-Saving balloon study halted early

NCT ID NCT05755412

Terminated Disease control Sponsor: EndoCore Lab s.r.l. Source: ClinicalTrials.gov ↗

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

Summary

This study tested a special balloon that uses sound waves (shockwaves) to crack open hard calcium blockages in the leg arteries of people with critical limb ischemia, a condition where poor blood flow can lead to pain, wounds, or even amputation. The goal was to see if the balloon was safe and effective at restoring blood flow and preventing the need for repeat procedures. However, the study was stopped early and only enrolled 9 people, so the results are very limited.

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Conditions

The condition(s) this trial relates to.

limb ischemia peripheral arterial disease

As listed by the trial registrant

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

CRITICAL LIMB-THREATENING ISCHAEMIA PERIPHERAL ARTERIAL DISEASE

Contacts and locations

Locations

Azienda Sanitaria Universitaria ed Integrata Santa Maria della Misericordia Udine (ASU FC)

Udine, 33100, Italy
Casa di Cura Abano Terme

Abano Terme, Padova, 35031, Italy
I.R.C.C.S. MultiMedica

Sesto San Giovanni, Milano, 20099, Italy
IRCCS - Azienda Ospedaliera-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, 40138, Italy
Ospedale "Morgagni di Forlì

Forlì, 47121, Italy
Ospedale Pederzoli

Peschiera del Garda, Veneto, 37019, Italy

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