NCT04010045终止不适用
REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
Ra Medical Systems1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Vessel Patency
研究概览
简要总结
This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
详细描述
This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant's age ≥ 22 years.
- •Participant presents with a Rutherford category of 2 to
- •Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System.
- •Participant is able and willing to be anti-coagulated.
- •Ability and willingness of participant to give written informed consent and comply with follow-up.
排除标准
- •Pregnant, breastfeeding, planning to become pregnant - If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
- •Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
- •Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
- •Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
- •Inability or unwillingness of the patient to comply with study examinations.
- •Necrosis necessitating major amputation.
- •Subject has an anticipated life span of less than one (1) year.
- •Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels).
- •No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.
结局指标
主要结局
Vessel Patency
时间窗: 24 months
Patency of the target lesion at 24 months, as determined by duplex ultrasound.
次要结局
- Serious Adverse Events(1 day, 6 months, 12 months, 18 months, and 24 months)
- Vessel Patency(6 months, 12 months, and 18 months)
研究者
研究点 (1)
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