NL-OMON48317撤回不适用
Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia - CLI 15-03
William Cook Europe ApS0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 50
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
- •A patient is deemed suitable for inclusion in the study if the patient meets
- •all of the following criteria at the time of enrollment:
- •1. Critical limb ischemia in the study leg with ischemic rest pain and/or
- •ulcer/minor tissue loss (Rutherford 4 or 5)
- •2. Total ulcerated area of the study leg 0 * 40 cm2 with no exposed bone
- •3. Has previously failed an endovascular or surgical treatment of the study
- •lower leg and is not being considered for additional intervention within the
- •next 3 months, OR is unsuitable for revascularization (*poor option*: e.g., has
- •exhausted endovascular options and standard veins as surgical conduit, or is
- •not a good surgical candidate)
排除标准
- •Patients must be excluded from the study if any of the following are true at
- •time of enrollment:
- •General study criteria:
- •1. Age < 18 years or > 85 years
- •2. Unable or unwilling to provide informed consent
- •3. Unable or unwilling to comply with the study follow-up schedule
- •4. Simultaneously participating in another investigational study (e.g., drug or
- •device). The patient must have completed the follow-up phase for the primary
- •endpoint of any previous investigational study at least 30 days prior to
- •enrollment in this study.
- •5. Pregnant or breastfeeding, or planning to become pregnant within the next 12
- •6. Major surgery (e.g., open cardiac, vascular, or abdominal procedure) within
- •the past 90 days
- •7. Endovascular intervention within the past 30 days
- •8. Planned surgical or interventional procedure within 4 months after the
- •initial study procedure (except standard wound debridement, minor toe
- •amputations, and minor office procedures; these are acceptable)
- •Overall health and comorbidities:
- •9. Medical condition that limits life expectancy to less than 12 months
- •10. Diabetes mellitus not under control (HgbA1c > 10%)
- •11. Current active proliferative diabetic retinopathy
- •12. Current dialysis, or expected to need dialysis within the next 12 months
- •13. Suppressed immune system due to systemic therapy or disease (e.g., organ
- •transplant recipient, AIDS, etc.)
- •14. Hypersensitivity or contraindication to the use of anesthesia or contrast
- •dye (as needed for angiography and/or study procedures), which, in the opinion
- •of the investigator, cannot be adequately pre-medicated
- •15. Congestive heart failure (NYH class III or IV)
- •16. History of blood cancer
- •17. History of solid cancer within the past 5 years (excluding basal or
- •squamous cell carcinomas)
- •18. History of myocardial infarction or stroke within the past 12 months
- •Study leg characteristics:
- •19. Ischemia or extensive necrosis above the transmetatarsal level of the study
- •leg expected to require amputation within the next 3 months or is considered
- •Rutherford Category 6
- •20. Previous above the ankle amputation in the study leg
- •21. Current infection in the study leg, including but not limited to
- •osteomyelitis and/or cellulitis
- •22. Uncorrected stenosis > 70% in the proximal arteries above the knee of the
- •Blood product- or procedure-related:
- •23. Known sickle cell trait
- •24. White blood cell count < 4,500/*L or > 20,000/*L
- •25. Hematocrit < 32% for men, or < 28% for women
- •Medications:
- •26. Patients at high risk of bleeding (e.g., taking a direct thrombin
- •inhibitor, taking warfarin and unable to suspend medication prior to IM
- •injections)
研究者
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