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

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)

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10 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: Micronized Small Intestinal Submucosa (SIS)