Cook Micronized Small Intestinal Submucosa (SIS) for Crit... | NCT02044666

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

NCT02044666

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Jan 6, 2017Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases

Interventions

Micronized Small Intestinal Submucosa (SIS)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2017

Last Update Posted Date

Jan 6, 2017Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: Micronized Small Intestinal Submucosa (SIS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micronized Small Intestinal Submucosa (SIS)	Device	Micronized Small Intestinal Submucosa (SIS)	Treatment

Measure	Description	Time Frame
Frequency and types of adverse events		180 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kong Teng Tan, MD	Toronto General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto General Hospital		Toronto	Ontario	M5G 1X6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007511	Ischemia
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D050197	Atherosclerosis
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided