PDF(Pubmed)
Abstract：
UNASSIGNED: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients.
UNASSIGNED: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years.
UNASSIGNED: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
UNASSIGNED: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years.
UNASSIGNED: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
摘要：
■严重的威胁肢体缺血（CLTI）是一种严重的疾病，其特征是静息疼痛和缺血性组织丢失，影响5％至10％的外周动脉疾病患者。在美国,很少有美国食品和药物管理局批准的用于膝关节以下动脉（BTK）主要治疗的设备。不幸的是,所有人都因内膜增生而遭受高再狭窄率，弹性反冲，和未经处理的解剖，因为缺乏脚手架。EspritBTK系统是一种可吸收的，药物洗脱支架装置有可能解决由于膝下动脉粥样硬化而患有CLTI的人的未满足的需求。LIFE-BTK（膝关节以下药物洗脱可吸收支架治疗的安全性和功效调查）随机对照试验（RCT）是对EspritBTK药物洗脱可吸收支架的前瞻性设计的上市前评估用于治疗这些患者。
■LIFE-BTK试验招募了261名CLTI受试者进行RCT，另外7名受试者进行了药代动力学亚研究。RCT的目的是评估EspritBTK支架与经皮腔内血管成形术相比的安全性和有效性。主要疗效终点是12个月时保肢和主要通畅的复合终点。主要的安全终点是在6个月和30天没有重大的不良肢体事件和围手术期死亡。分别。临床随访计划为5年。
■如果我们要改善这一具有挑战性的患者组的预后，必须在随机对照试验中测试新型设备，以评估其安全性和有效性，与护理标准相比。
■LIFE-BTK试验招募了261名CLTI受试者进行RCT，另外7名受试者进行了药代动力学亚研究。RCT的目的是评估EspritBTK支架与经皮腔内血管成形术相比的安全性和有效性。主要疗效终点是12个月时保肢和主要通畅的复合终点。主要的安全终点是在6个月和30天没有重大的不良肢体事件和围手术期死亡。分别。临床随访计划为5年。
■如果我们要改善这一具有挑战性的患者组的预后，必须在随机对照试验中测试新型设备，以评估其安全性和有效性，与护理标准相比。
