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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02044666

Enrollment

Registered

2014-01-24

Start date

2014-02-28

Completion date

2016-08-31

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases

Keywords

Critical Limb Ischemia, Amputation

Brief summary

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

Interventions

DEVICEMicronized Small Intestinal Submucosa (SIS)

Micronized Small Intestinal Submucosa (SIS)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency and types of adverse events	180 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026