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

N/ACompletedNCT02044666

Cook Group Incorporated10 enrolled

Overview

This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases

Interventions

Micronized Small Intestinal Submucosa (SIS)DEVICE

Micronized Small Intestinal Submucosa (SIS)

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Toronto General Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Frequency and types of adverse events

Time frame: 180 days

Data from ClinicalTrials.gov

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