CompletedNot Applicable

Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

Canada10 participantsStarted 2014-02

Plain-language summary

This study is intended to collect safety and effectiveness data on the Cook Micronized 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: * Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB * Patient is unable to be treated by endovascular or surgical means Exclusion Criteria: * Patient is pregnant or breastfeeding * Patient has had a previous surgery within 30 days of the study procedure * Patient has a planned surgical or interventional procedure within 30 days after the study procedure * Patient has a life expectancy of 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 protocol

What they're measuring

Frequency and types of adverse events

Timeframe: 180 days

Trial details

NCT IDNCT02044666

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03

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