NCT02145845

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 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

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

3.2 years

First QC Date

May 21, 2014

Last Update Submit

December 19, 2017

Conditions

Critical Limb IschemiaPeripheral Arterial DiseasePeripheral Vascular Disease

Keywords

critical limb ischemiawound healingamputation

Outcome Measures

Primary Outcomes (1)

  • Frequency and types of adverse events after treatment with the Cook Injectable SIS

    180 days

Study Arms (1)

Treatment

EXPERIMENTAL

Injectable SIS

Device: Injectable SIS

Interventions

Injectable SISDEVICE

Injectable SIS

Treatment

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of critical limb ischemia
  • Rutherford 4-5 or Leriche-Fontaine IIIB
  • Patient unable to be treated by endovascular or surgical means

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaPeripheral Arterial DiseasePeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Vaclav Prochazka, MD

    University Hospital Ostrava

    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

May 21, 2014

First Posted

May 23, 2014

Study Start

April 1, 2014

Primary Completion

June 5, 2017

Study Completion

November 6, 2017

Last Updated

December 21, 2017

Record last verified: 2017-12

Locations

CZ(1)