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NCT02044666 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

Official title:
Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02044666
Other study ID # 13-004
Secondary ID
Status Completed
Phase N/A
First received January 22, 2014
Last updated January 5, 2017
Start date February 2014
Est. completion date August 2016

Study information
Verified date January 2017
Source Cook
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Micronized Small Intestinal Submucosa (SIS)
Micronized Small Intestinal Submucosa (SIS)

Locations
Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and types of adverse events 180 days Yes
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