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New balloon treatment for leg artery disease shows promise in Real-World study

NCT ID NCT07431437

Disease control Sponsor: Genoss Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study follows 300 people with blocked leg arteries who received a treatment using a balloon coated with paclitaxel and vitamin E. The goal is to see if the balloon keeps the artery open and prevents the need for repeat procedures over one year. Participants are adults with moderate to severe symptoms, and the study is observational, meaning no extra treatments are given beyond standard care.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient with percutaneous transluminal angioplasty with GENOSS® PCB in the femoropopliteal artery disease

Ages

19 to 85 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Enrollment in the study was limited to patients who met the following inclusion criteria: 1. Subject was ≥19 years of age. 2. Subject had target limb Rutherford classification 2, 3, 4 or 5. 3. Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB. 4. At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography. 5. Subject provided written informed consent and was willing to comply with the study follow-up requirements. Exclusion Criteria: Patients were not permitted to enroll in the study if they met any of the following exclusion criteria: 1. Subjects was allergic to paclitaxel. 2. Subjects with contraindications or hypersensitivity to antiplatelet therapy. 3. Subject had life expectancy of less than 2 years. 4. Women who were pregnant, breast-feeding or intended to become pregnant. 5. Subject was participating in another investigational drug or medical device study. 6. Subject was unwilling or unable to comply with procedures specified in the protocol or had difficulty or inability to return for follow-up visits as specified by the protocol.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease persistent truncus arteriosus

As listed by the trial registrant

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

Femoropopliteal artery disease Pta (percutaneous transluminal angioplasty)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Korea University Guro Hospital

    Seoul, Seoul, 08308, South Korea

More trials for these conditions

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