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Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

NCT ID: NCT02145845

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-11-06

Brief Summary

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

Detailed Description

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Conditions

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Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease

Keywords

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critical limb ischemia wound healing amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Injectable SIS

Group Type EXPERIMENTAL

Injectable SIS

Intervention Type DEVICE

Injectable SIS

Interventions

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Injectable SIS

Injectable SIS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vaclav Prochazka, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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11-013

Identifier Type: -

Identifier Source: org_study_id