PTA (Percutaneous Transluminal Angioplasty)NCT07431437
One-Year Results of GENOSS PCB Real-World Study in 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.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal artery disease. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2025to 30 Jun 2028
- 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
- Adult, Older adult
Study population: Patient with percutaneous transluminal angioplasty with GENOSS® PCB in the femoropopliteal artery disease
Who may be able to join
- Enrollment in the study was limited to patients who met the following inclusion criteria:
- Subject was ≥19 years of age.
- Subject had target limb Rutherford classification 2, 3, 4 or 5.
- Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
- At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
- Subject provided written informed consent and was willing to comply with the study follow-up requirements.
Who cannot join
- Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:
- Subjects was allergic to paclitaxel.
- Subjects with contraindications or hypersensitivity to antiplatelet therapy.
- Subject had life expectancy of less than 2 years.
- Women who were pregnant, breast-feeding or intended to become pregnant.
- Subject was participating in another investigational drug or medical device study.
- 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.
About this study
Official title: One-Year Results of GENOSS PCB (Paclitaxel-coated Balloon With a Shellac Plus Vitamin E Excipient) Real-World Study in Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study (GENOSS PCB-F/P)
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal artery disease.
Read the detailed description
This prospective, multicenter, single-arm, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 6 hospitals.
Because this is an observational study, the number of participants will not be calculated separately, but a total of 300 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 group | Role | What they receive |
|---|---|---|
| GENOSS® Peripheral DCB PTA Catheter | Patient 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.
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
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)
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
Change in Rutherford classification
Clinical improvement as assessed by changes in target limb Rutherford classification from baseline. Scores on the Rutherford classification range from 0 to 6, with higher scores indicating a worse outcome (more severe peripheral artery disease).
Measured: at 1 month, 6 months, and 12 months post procedure
Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))
Change in ABI or TBI from baseline. The ABI is calculated as the ratio of systolic blood pressure at the ankle to that in the arm, and the TBI uses toe systolic pressure. Theoretical values range from 0 to 3.0 (or greater), with higher values up to the normal range indicating a better outcome (improved arterial perfusion). A lower index indicates more severe peripheral artery disease.
Measured: at 1 month, 6 months, and 12 months post procedure
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
Procedural success rate (%)
Procedural success is defined as residual stenosis of ≤ 50% by core laboratory
Measured: immediately post procedure
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
All-cause death (%)
Measured: at 12 months post procedure
Target vessel revascularization (TVR, %)
Measured: at 1 month, 6 months, and 12 months post procedure
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.
- First posted24 Feb 2026
- Study start17 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTA (Percutaneous Transluminal Angioplasty)Studies of the same condition, open and under way.
- More trials run by Genoss Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431437
- Sponsor's protocol ID
- CIP-DS1411-2
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Year Results of GENOSS PCB (Paclitaxel-coated Balloon With a Shellac Plus Vitamin E Excipient) Real-World Study in Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study (GENOSS PCB-F/P)
- ClinicalTrials.gov ID
- NCT07431437
- Acronym / sponsor ID
- CIP-DS1411-2
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal artery disease.
Detailed description
This prospective, multicenter, single-arm, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 6 hospitals.
Because this is an observational study, the number of participants will not be calculated separately, but a total of 300 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENOSS® Peripheral DCB PTA Catheter | – | –Patient treated with GENOSS PCB in the femoropopliteal artery disease |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with percutaneous transluminal angioplasty with GENOSS® PCB in the femoropopliteal artery disease
Key inclusion criteria (6 listed)
- Subject was ≥19 years of age.
- Subject had target limb Rutherford classification 2, 3, 4 or 5.
- Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
- At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
- Subject provided written informed consent and was willing to comply with the study follow-up requirements.
Key exclusion criteria (7 listed)
- Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:
- Subjects was allergic to paclitaxel.
- Subjects with contraindications or hypersensitivity to antiplatelet therapy.
- Subject had life expectancy of less than 2 years.
- Women who were pregnant, breast-feeding or intended to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary safety endpoint
Time frame: at 12 months post procedure
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.
The primary effectiveness endpoint
Time frame: at 12 months post procedure
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.
9 secondary outcomes
Target lesion revascularization (TLR, %)
Time frame: at 1 month, 6 months, and 12 months post procedure
Change in Rutherford classification
Time frame: at 1 month, 6 months, and 12 months post procedure
Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))
Time frame: at 1 month, 6 months, and 12 months post procedure
Device success rate (%)
Time frame: during the procedure
Procedural success rate (%)
Time frame: immediately post procedure
Clinical success rate (%)
Time frame: up to 1 week
All-cause death (%)
Time frame: at 12 months post procedure
Target vessel revascularization (TVR, %)
Time frame: at 1 month, 6 months, and 12 months post procedure
Major target limb amputation (%)
Time frame: at 12 months post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PTA (Percutaneous Transluminal Angioplasty)
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingObservational study
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
Recruiting
Skin Microcirculation in Patients With Lower Limb Atherosclerosis
Percutaneous Transluminal Angioplasty, Atherosclerosis of Arteries of the Extremities, Unspecified
Active, not recruitingObservational study
VITUS Post-Market Registry
Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
Enrolling by invitationObservational study
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
PTA (Percutaneous Transluminal Angioplasty ), Femoropopliteal Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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?
The sponsor lists 6 inclusion and 7 exclusion criteria. 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 11 Sep 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?
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 11 Sep 2026.