NL-OMON51946招募中不适用
A Non-Randomized Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions - CapBuster
Praxis Medical Devices Ltd.0 个研究点目标入组 13 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 13
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
- 18 至 99（—）
入选标准
- •1. Males > 18 years of age and Female patients of non child-bearing potential
- •2. Clinical diagnosis of peripheral arterial disease requiring
- •revascularization as evidenced by contrast, CT, or MR angiography
- •3. Rutherford Classification 2-5
- •4. Presence of infrapopliteal arterial de novo or restenotic chronic total
- •occlusion(s) (100% stenosis), with TIMI 0 flow, confirmed by angiography.
- •Vessel distal to the occlusion(s) must be visualized per collateral or
- •retrograde flow. A maximum of 1 target occlusions can be treated per patient.
- •Target occlusion(s) can be in-stent restenosis
- •5. Target vessel(s) must be >= 2.5 mm and <= 3.25 mm in diameter proximal to the
- •target occlusion(s), by visual estimate
- •6. Target occlusions(s) cannot be crossed by conventional guidewire (crossing
- •time limited to <=5 minutes)
- •7. In the opinion of the investigator, life expectancy of > 1 year
- •8. Willing and able to sign the informed consent form
排除标准
- •1. Target occlusion is within a bypass graft
- •2. Target occlusion can be crossed by conventional guidewire
- •3. Target occlusion is below tibiotalar joint
- •4. Presence of acute limb ischemia
- •5. Known sensitivity or allergy to contrast materials that cannot be adequately
- •pre-treated
- •6. Known allergy or contraindication to all antiplatelet therapy
- •7. Subject has signs or symptoms of systemic infection/sepsis (temperature
- •>=38.0° Celsius and WBC >=12,000 cells/uL). If subject has localized infection,
- •including cellulitis or osteomyelitis, or infection is adequately treated and
- •controlled, per investigator discretion, patient may be enrolled.
- •8. Known or suspected myocardial infarction or stroke within previous 30 days
- •9. Significant acute or chronic renal disease with a GFR <30 mL/min/1.73m2
- •10. History of a surgical or endovascular procedure on the target limb within
- •30 days of the index procedure or non-target limb within 2 weeks of the index
- •11. Planned surgical or endovascular procedure prior to the subject*s 30-day
- •follow-up. Planned minor amputations are allowed.
- •12. Subject is scheduled for a target limb major amputation (above the ankle)
- •within 30 days post study procedure
- •13. Currently participating in another investigational drug or device study
- •14. Unwilling or unable to comply with the protocol or follow-up requirements
- •15. Any concurrent medical, psychological, or social condition, which may
- •significantly interfere with the subject*s optimal participation in the study,
- •in the opinion of the investigator
- •16. Female patients of child-bearing potential
研究者
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