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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENOSS® Peripheral DCB PTA Catheter | Patient treated with GENOSS PCB in the femoropopliteal artery disease |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | at 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 1 month, 6 months, and 12 months post procedure |
| Change in Rutherford classification |
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Inclusion Criteria:
Enrollment in the study was limited to patients who met the following inclusion criteria:
Exclusion Criteria:
Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:
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Patient with percutaneous transluminal angioplasty with GENOSS® PCB in the femoropopliteal artery disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
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| ID | Term |
|---|---|
| D014339 | Truncus Arteriosus, Persistent |
| ID | Term |
|---|---|
| D001028 | Aortopulmonary Septal Defect |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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Clinical improvement as assessed by changes in target limb Rutherford classification from baseline. |
| 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 | 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) | during the procedure |
| Procedural success rate (%) | Procedural success is defined as residual stenosis of ≤ 50% by core laboratory | 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. | up to 1 week |
| All-cause death (%) | at 12 months post procedure |
| Target vessel revascularization (TVR, %) | 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. | at 12 months post procedure |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |