Stent vs. scalpel: can a tiny tube replace surgery for leg artery disease?

NCT ID NCT04349657

Ongoing Disease control Sponsor: KANDO Research Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new stent (Supera) to standard surgery for treating blockages in the leg's main artery. About 286 people with moderate to severe leg pain or sores will be randomly assigned to get either the stent or surgery. Researchers will check if the stent keeps the artery open as well as surgery and if it causes fewer complications.

What this could mean

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

Active substance: Supera Peripheral Stent System
What this could lead to: If successful, this could offer a less invasive alternative to surgery for treating blocked leg arteries, potentially reducing recovery time and complications.
What could go wrong: This is a mid-stage trial with 286 participants. The stent may not work as well as surgery, or could cause complications like re-blockage or bleeding. Results may not apply to all patients.

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.

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

A.Z. Jan Portaels

Vilvoorde, 1800, Belgium
A.Z. Sint-Blasius

Dendermonde, 9200, Belgium
AZ Sint-Maarten

Mechelen, 2800, Belgium
Az Groeninge

Kortrijk, 8500, Belgium
Bonifraterskie Centrum Medyczne

Krakow, 31-061, Poland
Dijklander hospital

Hoorn, North Holland, 1624, Netherlands
Imelda Hospital

Bonheiden, 2820, Belgium
Karol Marcinkowski Medical University

Poznan, 61-848, Poland
Maastricht UMC+

Maastricht, Limburg, 6229, Netherlands
Noordwest ziekenhuisgroep

Alkmaar, 1815, Netherlands
O.L.V. Hospital

Aalst, 9300, Belgium
St Antonius Hospital

Utrecht, Utrecht, 3543, Netherlands
Z.O.L.

Genk, 3600, Belgium

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