Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

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

Completed

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 1X6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
Patient is unable to be treated by endovascular or surgical means

Exclusion criteria

Patient is pregnant or breastfeeding
Patient has had a previous surgery within 30 days of the study procedure
Patient has a planned surgical or interventional procedure within 30 days after the study procedure
Patient has a life expectancy of 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 protocol

Treatment and study plan

Micronized Small Intestinal Submucosa (SIS)

Device

Micronized Small Intestinal Submucosa (SIS)

Primary outcomes

Frequency and types of adverse events

Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jan 24, 2014
Registry last updated: Jan 6, 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