Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Not Applicable

Completed

• Conditions: Peripheral Vascular Disease; Critical Limb Ischemia; Peripheral Arterial Disease

• Registration Number: NCT02145845
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Primary Completion: 2017-06-05
• Study Completion: 2017-11-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency and types of adverse events after treatment with the Cook Injectable SIS	180 days

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Czechia