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NCT02145845 Clinical Trial

Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Peripheral Arterial Disease Clinical Trial

— CLIC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02145845
Other study ID # 11-013
Secondary ID
Status Completed
Phase N/A
First received May 21, 2014
Last updated December 19, 2017
Start date April 2014
Est. completion date November 6, 2017

Study information
Verified date December 2017
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date November 6, 2017
Est. primary completion date June 5, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of critical limb ischemia

- Rutherford 4-5 or Leriche-Fontaine IIIB

- Patient unable to be treated by endovascular or surgical means

Exclusion Criteria:

- Patient's age is <21

- Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)

- Patient has had a previous surgery, within 30 days of the study procedure

- Patient has any planned surgical or interventional procedure within 30 days after the study procedure

- Patient has a life expectancy 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 Clinical Investigation Plan

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Injectable SIS
Injectable SIS

Locations
Country Name City State
Czechia University Hospital Ostrava Ostrava

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and types of adverse events after treatment with the Cook Injectable SIS 180 days
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