Clinical Trials Logo
  1. Home
  2. Peripheral Arterial Disease
  3. NCT02145845
  4. Details
NCT02145845 Clinical Trial

Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Peripheral Arterial Disease Clinical Trial

— CLIC  

Official title:
Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02145845
Other study ID # 11-013
Secondary ID
Status Completed
Phase N/A
First received May 21, 2014
Last updated December 19, 2017
Start date April 2014
Est. completion date November 6, 2017

Study information
Verified date December 2017
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date November 6, 2017
Est. primary completion date June 5, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Injectable SIS
Injectable SIS

Locations
Country Name City State
Czechia University Hospital Ostrava Ostrava

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and types of adverse events after treatment with the Cook Injectable SIS 180 days
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Completed NCT02022423 - Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease N/A