NL-OMON48317
Withdrawn
N/A
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 sites50 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- William Cook Europe ApS
- Enrollment
- 50
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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