AzTrials
AzTrials

PTA (Percutaneous Transluminal Angioplasty )GENOSS PCBNCT07399080

Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease

An observational study of PTA (Percutaneous Transluminal Angioplasty ) and Femoropopliteal Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease. Read more about this study

Who is it for?
Ages 19 to 85 years
How many people
200 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2025to 30 Jun 2028
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

<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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

Other trials in South Korea

About this study

Official title: Real-World Clinical Outcomes of GENOSS PCB (Paclitaxel-coated Balloon) for Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study

The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease.

Read the detailed description

This prospective, open-label, multicenter, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 10 hospitals.

Because this is an observational study, the number of participants will not be calculated separately, but a total of 200 participants are planned to be recruited during the study period.

All patients will be followed up at 12 months postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTA balloon catheter.

Medical subject headings
Truncus Arteriosus, Persistent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07399080
Study groupRoleWhat they receive
GENOSS® Peripheral DCB PTA CatheterPatient treated with GENOSS PCB in the femoropopliteal artery disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary safety endpoint

    The primary safety endpoint is the Major Adverse Events (MAEs)-free rate, defined as a composite of freedom from all-cause death through 1month post procedure and/or freedom from both major target limb amputation and/or clinically-driven target lesion revascularization (TLR) through 12months post procedure.

    Measured: at 12 months post procedure

  2. The primary effectiveness endpoint

    The primary effectiveness endpoint is a primary patency, defined as a composite of freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from binary restenosis (restenosis defined as peak systolic velocity ratio [PSVR] ≥ 2.4 assessed by duplex ultrasound or ≥ 50% stenosis as assessed by CT angiography) through 12months post procedure.

    Measured: at 12 months post procedure

Secondary outcomes (9)

  1. Target lesion revascularization (TLR, %)

    TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI/TBI of ≥ 20% or > 0.15 when compared to post procedure baseline.

    Measured: at 1 month, 6 months, and 12 months post procedure

  2. Change in Rutherford classification

    Clinical improvement as assessed by changes in target limb Rutherford classification from baseline.

    Measured: at 1 month, 6 months, and 12 months post procedure

  3. Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))

    Change in ABI (ankle-brachial index) from baseline

    Measured: at 1 month, 6 months, and 12 months post procedure

  4. Device success rate (%)

    Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).

    Measured: during the procedure

  5. Procedural success rate (%)

    Procedural success is defined as residual stenosis of ≤ 50% by core laboratory.

    Measured: immediately post procedure

  6. Clinical success rate (%)

    Clinical success is defined as procedural success without complications (i.e. death, major target limb amputation, clinically-driven TLR) during the hospital stay post procedure.

    Measured: up to 1 week

  7. All-cause death (%)

    Measured: at 12 months post procedure

  8. Target vessel revascularization (TVR, %)

    Measured: at 1 month, 6 months, and 12 months post procedure

  9. Major target limb amputation (%)

    Major target limb amputation is defined as any amputation above the ankle on the target limb.

    Measured: at 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start1 Jul 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07399080
Sponsor's protocol ID
CIP-DS1411-1
Acronym
GENOSS PCB
Status last verified
Aug 2025
First submitted
30 Sep 2025
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of PTA (Percutaneous Transluminal Angioplasty ) and Femoropopliteal Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary safety endpoint (time frame: at 12 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07399080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in