CompletedNot Applicable

Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Czechia13 participantsStarted 2014-04

Plain-language summary

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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 180 days

Trial details

NCT IDNCT02145845

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-05

View on ClinicalTrials.gov More Critical Limb Ischemia trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.