Shockwave Treatment for Advanced Angina in Maastricht (SWAAM). A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Medispec
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Time to Angina
研究概览
简要总结
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.
详细描述
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.
At first, the patient undergoes stress-SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatment session (9 in total, spread over 9 weeks) are required for optimal results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is diagnosed with chronic stable angina pectoris, for a period of at least 3 months. Diagnosis is based on medical history, complete physical evaluation.
- •Patient has documented myocardial segments with reversible ischemia.
- •Patient is classified in AP CCS of III-IV.
- •Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- •Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
- •Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
- •Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- •Patient has signed an IRB approved informed consent form.
- •Patient's condition should be stable and should have a life expectancy of >12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.
排除标准
- •Patient is pregnant
- •Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- •Patient has active endocarditis, myocarditis or pericarditis.
- •Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
- •Patients who are unwilling or unable to cooperate with study procedure
结局指标
主要结局
Time to Angina
时间窗: 6 months
Change in time to angina using the modified Bruce exercise test from baseline to the 6 months post baseline assessment
次要结局
- Change in SPECT(6 months)
- Change in AP-CCS(6 months)
- Total Exercise time(6 months)
- Number of Angina attacks (patient diary)(6 months)