Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

N/ACompletedNCT02145845

Cook Group Incorporated13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease

Interventions

Injectable SISDEVICE

Injectable SIS

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Ostrava

Ostrava, Czechia

Outcomes

Primary Outcomes

Frequency and types of adverse events after treatment with the Cook Injectable SIS

Time frame: 180 days

Data from ClinicalTrials.gov

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