Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
- Conditions
- Critical Limb Ishemia and Peripheral Artery Disease1002530910003216
- Registration Number
- NL-OMON48317
- Lead Sponsor
- William Cook Europe ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
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)
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
months
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
study leg
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is clinical benefit through 12-month follow-up, defined as<br /><br>freedom from all the following:<br /><br>* Vascular or endovascular arterial intervention below the knee in the study leg<br /><br>* Major amputation in the study leg<br /><br>* Death (all-cause)</p><br>
- Secondary Outcome Measures
Name Time Method <p>In addition to the primary endpoint, the following secondary endpoints will be<br /><br>assessed:<br /><br>* Incidence of major amputation of the study leg through 12 months<br /><br>* Incidence of vascular or endovascular arterial intervention below the knee in<br /><br>the study leg through 12 months<br /><br>* Death (all-cause) through 12 months<br /><br>* Change in total ulcerated area of the study leg through 12 months</p><br>