Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

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

Completed

Looking for future studies?

Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, 708 52, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injectable SIS

Device

Injectable SIS

Primary outcomes

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

Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Acronym: CLIC

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 23, 2014
Registry last updated: Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed