PTA (Percutaneous Transluminal Angioplasty)NCT07425171
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
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 in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB. 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, Long Femoropopliteal Artery Disease
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2026to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with long femoropopliteal lesions who underwent percutaneous angioplasty using GENOSS PCB
<Inclusion criteria>
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.
- Subjects with a stenosis of 70% or greater in the femoropopliteal artery.
- Subjects with a stenotic or occlusive lesion measuring ≥150 mm in total length. (Multiple adjacent lesions separated by less than 3 cm from angiographically healthy segments are treated as a single lesion.)
- Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.
- 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:
- Subjects was allergic to paclitaxel.
- Subjects with contraindications or hypersensitivity to antiplatelet therapy.
- Subject had life expectancy of less than 2 years.
- Those who have undergone vascular surgery on the target lesion within the past 6 weeks.
- Those who have in-stent restenosis (ISR) on the target lesion.
- Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.
- Women who were pregnant, breast-feeding or intended to become pregnant.
- Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device.
- Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement.
- Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.
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, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
+82312194466, ajouirb@aumc.ac.kr
Je Hwan Won, Radiology
About this study
Official title: Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
Read the detailed description
This is a prospective, multicenter, single-arm, observational study designed to evaluate the long-term safety and effectiveness of the GENOSS paclitaxel-coated balloon (PCB) in patients with long femoropopliteal artery lesions treated with percutaneous transluminal angioplasty (PTA).
The study will enroll patients who undergo PTA using the GENOSS PCB at 4 hospitals. Approximately 300 patients are planned to be enrolled during the study period.
All enrolled patients will be followed for 12 months after the index procedure to assess the long-term safety and effectiveness of the GENOSS PCB. Additionally, the primary endpoints, major adverse event-free rate and primary patency, will be assessed during follow-up.
- Conditions
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease
- 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 | Patients with long femoropopliteal artery disease treated with the GENOSS paclitaxel-coated balloon (PCB) |
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.
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 (ankle-brachial index) from baseline
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 posted20 Feb 2026
- Study start13 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 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
- NCT07425171
- Sponsor's protocol ID
- CIP-DS1411-3
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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
- Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)
- ClinicalTrials.gov ID
- NCT07425171
- Acronym / sponsor ID
- CIP-DS1411-3
- Conditions
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 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 in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
Detailed description
This is a prospective, multicenter, single-arm, observational study designed to evaluate the long-term safety and effectiveness of the GENOSS paclitaxel-coated balloon (PCB) in patients with long femoropopliteal artery lesions treated with percutaneous transluminal angioplasty (PTA).
The study will enroll patients who undergo PTA using the GENOSS PCB at 4 hospitals. Approximately 300 patients are planned to be enrolled during the study period.
All enrolled patients will be followed for 12 months after the index procedure to assess the long-term safety and effectiveness of the GENOSS PCB. Additionally, the primary endpoints, major adverse event-free rate and primary patency, will be assessed during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENOSS® Peripheral DCB PTA Catheter | – | –Patients with long femoropopliteal artery disease treated with the GENOSS paclitaxel-coated balloon (PCB) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with long femoropopliteal lesions who underwent percutaneous angioplasty using GENOSS PCB
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
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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.
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?
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: looking for participants now, 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?
Contact Je Hwan Won, Radiology (+821092655132, wonkwak@ajou.ac.kr), or a site near the patient. 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.