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

C

Cook Group

Status

Completed

Conditions

Peripheral Vascular Diseases
Ischemia
Peripheral Arterial Disease

Treatments

Device: Micronized Small Intestinal Submucosa (SIS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02044666
13-004

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

21+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Treatment
Experimental group
Treatment:
Device: Micronized Small Intestinal Submucosa (SIS)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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