SOL JAPAN Clinical Trial: Safety and Efficacy Study of BP-DPC18 for the treatment of Femoropopliteal Artery Lesions in Japan (SOL JAPAN)

MEDICO'S HIRATA INC.0 个研究点目标入组 120 人开始时间: 2021年2月16日最近更新: 2025年6月6日

试验速览

暂无简介。

•(1) Subject has symptomatic peripheral artery disease (PAD) of the native femoropopliteal artery with Rutherford classification 2, 3, and
•(2) Subject is able to verbally acknowledge and understand the aim of this trial and the trial period and is willing and able to provide informed consent and comply with all requirements for clinical visits and assessment during the follow-up period.

•(1) History of hemorrhagic stroke or ST-Elevation Myocardial Infarction (STEMI) within 3 months prior to enrollment
•(2) Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
•(3) Chronic renal insufficiency with serum creatinine >2.0 mg/dL
•(4) Any major (e.g. cardiac, peripheral, abdominal) intervention (including in the contralateral femoral-popliteal artery) was performed within 30 days pre index procedure or is planned within 30 days post index procedure.
•(5) Diagnosis of bleeding diathesis or hypercoagulable state
•(6) Subject has an infectious disease that requires systemic treatment.
•(7) Subject has mental illness or coexisting mental symptoms that interfere with daily life, and has difficulty participating in the trial.
•(8) Subject is participating in another trial or intervention involving a medical device, and a pharmaceutical and biological drug product.
•(9) Life expectancy, of at least 1 year
•(10) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children.

Primary patency of the target within 12 months from procedure.

发起方