JPRN-UMIN000004031已完成未知
Clinical evaluation of efficacy and safety of paclitaxel-eluting balloon (PEB) for peripheral artery disease patients with femolo-popliteal lesion - Clinical evaluation of PEB for peripheral artery disease patients (PADPEB study)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(General) When study patients are 1. Unwilling or unlikely to comply with the follow-up schedule 2. Given local or systematic thrombolytic therapy within 48 hours prior to the procedure 3. Allergic to heparin, aspirin, clopidogrel, ticlopidine, cilostazol, and other anticoagulants, antiplatelet therapies, contrast media, and/or paclitaxel 4. Diagnosed as having bleeding diatheses or hypercoagulable states 5. Enrolled in another device, drug, or biologic study whose follow-up period has not completed 6. Pregnant (Anatomic) 1. Ipsilateral iliac artery lesions with severe stenosis (>=70% by visual estimate) or occlusion which are not treated or have not obtained a successful residual stenosis (<30% by visual estimate) # Ipsilateral iliac artery lesions must be treated >=30 days prior to patient randomization and target lesion treatment. 2. Ispsilateral iliac artery lesions treated without drug-eluting stent and/or PEB 3. Unsuccessful treatment of any lesions in the contralateral limb # Contralateral limb lesions must be treated >=30 days prior to patient randomization and target lesion treatment. 4. A second lesion within the target femolo-popliteal artery 5. Failure to cross the true lumen of target lesion with a guidewire 6. Lesions within or adjacent to an aneurysm 7. Acute or subacute thrombus in the target vessel 8. A history of bypass surgery in the target lesion 9. A severe calcification by angiography which leads to a low expectation of successful dilation by balloon 10. Expectation of single treatment difficulty without other alternative therapies such as stent, laser, cutting balloon, and rotablator # Bail-out stenting is permitted if needed
研究者
相似试验
尚未招募
4 期
CLINICAL TRIAL ONPALSINURON CAPSULE FOR TREATMENT OF DIABETIC NEUROPATHYCTRI/2017/07/009087Ms SG Phyto Pharma Private Limited
已完成
1 期
Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstructiorupture of anterior cruciate ligamentJPRN-UMIN000014694niversity of tsukuba Department of Orthopaedic Surgery5
招募中
4 期
Comparative study of chemotherapy in esophagus carcinoma.CTRI/2014/04/004516Tata Memorial Hospital350
尚未招募
3 期
Effect of Palashudumbaradi Lepam followed by Kapikacchu mooldhavanam along with yogic practices in Pelvic Organ ProlapseCTRI/2023/05/052213principal
尚未招募
不适用
A study to evaluate the efficacy of Phalatrikadi Kashaya and Daruharidraghana Vati in Non- Alcoholic Fatty Liver DiseaseCTRI/2021/05/033410RGGPG Ayurvedic College and Hospital