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New balloon could improve treatment for blocked leg arteries

NCT ID NCT07144150

Recruiting now Disease control Sponsor: Cook Research Incorporated Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new balloon coated with everolimus to standard paclitaxel-coated balloons for opening blocked leg arteries in people with peripheral artery disease. About 410 participants will be randomly assigned to one of the two balloons. The goal is to see if the new balloon is as safe and effective at keeping arteries open after one year.

What this could mean

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

Active substance

everolimus-coated balloon catheter

What this could lead to

If it works, this could offer a new treatment option for blocked leg arteries, potentially with fewer side effects than current drug-coated balloons.

What could go wrong

This is an early-stage comparison study, not a cure. The new balloon may not be as effective or safe as existing ones, and results may not apply to all patients.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

intermittent vascular claudication peripheral arterial disease peripheral vascular disease

As listed by the trial registrant

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

PERIPHERAL ARTERIAL DISEASE PERIPHERAL VASCULAR DISEASE

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Baptist Cardiac and Vascular Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • First Coast Cardiovascular Institute

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Prisma Health Memorial

    RECRUITING

    Greenville, South Carolina, 26905, United States

  • The Cardiac and Vascular Institute

    RECRUITING

    Gainesville, Florida, 32605, United States