Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Re-stenosis rates between 6 months and 12 months
研究概览
简要总结
The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.
详细描述
Background
Currently, DM foot admissions account for up to 2% of all admissions in CGH, with up to 50% of patients with peripheral vascular disease (PVD). CGH Vascular service performs 100-150 peripheral angioplasties for limb ischaemia per 6 months, the majority of which are for limb salvage procedures. The angioplasty procedure is performed below the knee (BTK) and the BTK vessels are involved in more than 80% of the time. Restenosis is common in peripheral interventions.
In the recently published DESTINY trial, the superiority of Everolimus DES (XIENCE, Abbott Vascular) was proven over BMS (Bare Metal Stents). This landmark study suggests that for short lesions in the BTK segment, DES improved patency rates and reduced the need for re-interventions for restenosis.
Re-interventions for previously stented arteries are technically difficult. In the coronary bed, the Bioabsorbable stents have been developed to provide the functions of a drug eluting stent but yet provide a temporary scaffold to allow the vessel to heal. The absence of a permanent metallic implant in the vascular tissue may facilitate any required re-interventions on the target vessel / lesion or side branches either by percutaneous or surgical means, thus enabling a broader range of treatment options after bioresorption of the scaffold. In addition, unlike permanent metal implants, polymeric implants do not cause imaging artifacts during non-invasive CT or MR evaluation providing additional benefit
Rationate and justification for the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
- •A maximum of 2 target lesions in one or more infrapopliteal vessels
- •Minimum of 1mm overlap of stents
- •Reference vessel diameter should be 2-4.0 mm
- •Symptomatic critical limb ischemia (Rutherford 4, 5, 6)
- •The patient must be > 21 years of age
- •Life-expectancy of more than 12 months
- •The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
- •The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
- •The patient must provide written patient informed consent
排除标准
- •Patient refusing treatment
- •The reference segment diameter is not suitable for available stent design
- •Unsuccessfully treated (>50% residual stenosis) proximal inflow limiting arterial stenosis
- •Untreatable lesion located at the distal outflow arteries
- •Lesion location requiring kissing stent procedure
- •The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
- •The patient takes Phenprocoumon (Marcumar).
- •The patient is currently breast-feeding, pregnant or intends to become pregnant.
- •Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
- •Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure to the target vessel
结局指标
主要结局
Change in Re-stenosis rates between 6 months and 12 months
时间窗: 6 months and 12 months
defined at stenosis \>=50% of the treated segment on duplex ultrasound, CT angiography or MR angiography
次要结局
- Change in Mean Transcutaneous oxygen measurement (TCOMs) between 6 months and 12 months(6 and 12 months)
- Change in Amputation free survival between 6 months and 12 months(6 months and 12 months)
- Change in Freedom from Target lesion revascularization between 6 months and 12 months(6 and 12 months)
- Change from baseline in Rutherford class at 6 months and 12 months(Baseline, 6 and 12 months)
- Number of Participants with major adverse limb events (MALE)(within 1 year)
- Number of Participants with Peri-procedural death (POD)(within 30-day)