Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
NCT ID: NCT02145845
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13 participants
INTERVENTIONAL
2014-04-30
2017-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
NCT02044666
A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
NCT02358629
Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
NCT06310174
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
NCT07219758
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
NCT07095660
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Injectable SIS
Injectable SIS
Injectable SIS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Injectable SIS
Injectable SIS
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Rutherford 4-5 or Leriche-Fontaine IIIB
* Patient unable to be treated by endovascular or surgical means
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cook Group Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vaclav Prochazka, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Ostrava
Ostrava, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11-013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.