NCT02044666

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

January 22, 2014

Last Update Submit

January 5, 2017

Conditions

IschemiaPeripheral Arterial DiseasePeripheral Vascular Diseases

Keywords

Critical Limb IschemiaAmputation

Outcome Measures

Primary Outcomes (1)

  • Frequency and types of adverse events

    180 days

Study Arms (1)

Treatment

EXPERIMENTAL
Device: Micronized Small Intestinal Submucosa (SIS)

Interventions

Micronized Small Intestinal Submucosa (SIS)DEVICE

Micronized Small Intestinal Submucosa (SIS)

Treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
  • Patient is unable to be treated by endovascular or surgical means

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1X6, Canada

Location

MeSH Terms

Conditions

IschemiaPeripheral Arterial DiseasePeripheral Vascular DiseasesChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Kong Teng Tan, MD

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

CA(1)