Back to resultsCook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
Primary Purpose
Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Micronized Small Intestinal Submucosa (SIS)
Sponsored by
About this trial
This is an interventional treatment trial for Ischemia focused on measuring Critical Limb Ischemia, Amputation
Eligibility Criteria
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
Sites / Locations
- Toronto General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Frequency and types of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT02044666
First Posted
January 22, 2014
Last Updated
January 5, 2017
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT02044666
Brief Title
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
Official Title
Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
Brief Summary
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
Keywords
Critical Limb Ischemia, Amputation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Micronized Small Intestinal Submucosa (SIS)
Intervention Description
Micronized Small Intestinal Submucosa (SIS)
Primary Outcome Measure Information:
Title
Frequency and types of adverse events
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MD
Organizational Affiliation
Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
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