Pilot Safety Study of Injectable SIS for Critical Limb Ischemia (CLIC)

Cook Group

Status: Completed

Conditions: Peripheral Vascular Disease; Critical Limb Ischemia; Peripheral Arterial Disease

Treatments: Device: Injectable SIS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02145845

11-013

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Treatment

Experimental group

Description:

Injectable SIS

Treatment:

Device: Injectable SIS