One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease. Basic parameters: 19 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Primary outcome measures
- The primary safety endpoint [Time frame: at 12 months post procedure]
- The primary effectiveness endpoint [Time frame: at 12 months post procedure]
Secondary outcome measures (9)
- 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]
Eligibility criteria
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.
- 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.
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Korea University Guro Hospital — Seoul
Identifiers
NCT: NCT07431437 · CIP-DS1411-2