Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease, PTA (Percutaneous Transluminal Angioplasty)
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Genoss Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
\<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. Subjects with a stenosis of 70% or greater in the femoropopliteal artery. 4. 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.) 5. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm. 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary safety endpoint | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion revascularization (TLR, %) | at 1 month, 6 months, and 12 months post procedure | 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. |
| Change in Rutherford classification | at 1 month, 6 months, and 12 months post procedure | Clinical improvement as assessed by changes in target limb Rutherford classification from baseline. |
| Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index)) | at 1 month, 6 months, and 12 months post procedure | Change in ABI (ankle-brachial index) from baseline |
| Device success rate (%) | during the procedure | 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). |
| Procedural success rate (%) | immediately post procedure | Procedural success is defined as residual stenosis of ≤ 50% by core laboratory. |
| Clinical success rate (%) | up to 1 week | 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. |
| 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 (%) | at 12 months post procedure | Major target limb amputation is defined as any amputation above the ankle on the target limb. |
Countries
South Korea
Contacts
CONTACTJe Hwan Won, Radiology
Outcome results
None listed