Pilot Safety Study of Injectable SIS for Critical Limb Ischemia (NCT02145845) | Clinical Trial Compass
CompletedNot Applicable
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
Czechia13 participantsStarted 2014-04
Plain-language summary
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Frequency and types of adverse events after treatment with the Cook Injectable SIS