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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases; Ischemia
• Interventions: Device: Micronized Small Intestinal Submucosa (SIS)

• Registration Number: NCT02044666
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-02
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Micronized Small Intestinal Submucosa (SIS)	-

Primary Outcome Measures

Name	Time	Method
Frequency and types of adverse events	180 days

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada