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

NCT ID: NCT02044666

Last Updated: 2017-01-06

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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Conditions

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Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases

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

Group Type EXPERIMENTAL

Micronized Small Intestinal Submucosa (SIS)

Intervention Type DEVICE

Micronized Small Intestinal Submucosa (SIS)

Interventions

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Micronized Small Intestinal Submucosa (SIS)

Micronized Small Intestinal Submucosa (SIS)

Intervention Type DEVICE

Eligibility Criteria

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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
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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Kong Teng Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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13-004

Identifier Type: -

Identifier Source: org_study_id

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