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โ† Trials
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Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion

Recruitingn/aAges 19 Years - 85 YearsAllGenoss Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
\<Inclusion criteria\> Enrollment in the study was limited to patients who met the following inclusion criteria: 1. Subject was โ‰ฅ19 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 โ‰ฅ150 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 โ‰ฅ4 mm but โ‰ค7 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 exclusion criteria: 1. Subjects was allergic to paclitaxel. 2. Subjects with contraindications or hypersensitivity to antiplatelet therapy. 3. Subject had life expectancy of less than 2 years. 4. Those who have undergone vascular surgery on the target lesion within the past 6 weeks. 5. Those who have in-stent restenosis (ISR) on the target lesion. 6. Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion. 7. Women who were pregnant, breast-feeding or intended to become pregnant. 8. Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device. 9. Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement. 10. Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.
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What it tests

  • Not listed
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Where

1 site
Ajou University Hospital
Suwon, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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