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 Aug 13, 2026 · Updated 6 times

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.

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.

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

Locations

Baptist Cardiac and Vascular Institute
RECRUITING

Miami, Florida, 33176, United States
First Coast Cardiovascular Institute
RECRUITING

Jacksonville, Florida, 32256, United States
Houston Methodist Hospital
RECRUITING

Houston, Texas, 77030, United States
Midwest Cardiovascular Research Foundation
RECRUITING

Davenport, Iowa, 52801, United States
North Mississippi Medical Center
RECRUITING

Tupelo, Mississippi, 33801, United States
Prisma Health Memorial
RECRUITING

Greenville, South Carolina, 26905, United States
The Cardiac and Vascular Institute
RECRUITING

Gainesville, Florida, 32605, United States
Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06510, United States

More trials for these conditions

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