NCT02145845CompletedNot Applicable
Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cook Group Incorporated
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Frequency and types of adverse events after treatment with the Cook Injectable SIS
Study Overview
Brief Summary
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of critical limb ischemia
- •Rutherford 4-5 or Leriche-Fontaine IIIB
- •Patient unable to be treated by endovascular or surgical means
Exclusion Criteria
- •Patient's age is <21
- •Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
- •Patient has had a previous surgery, within 30 days of the study procedure
- •Patient has any planned surgical or interventional procedure within 30 days after the study procedure
- •Patient has a life expectancy less than 1 year
- •Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue
- •Additional restrictions as specified in the Clinical Investigation Plan
Outcomes
Primary Outcomes
Frequency and types of adverse events after treatment with the Cook Injectable SIS
Time Frame: 180 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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