Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Not Applicable

Completed

• Conditions: Peripheral Vascular Disease; Critical Limb Ischemia; Peripheral Arterial Disease
• Interventions: Device: Injectable SIS

• 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

Arm && Interventions

Group	Intervention	Description
Treatment	Injectable SIS	Injectable SIS

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