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Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix) (RECON)

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ClinicalTrials.gov Identifier: NCT02073331
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : October 4, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Aziyo Biologics, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Coronary Disease
Enrollment 1420
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CorMatrix ECM
Hide Arm/Group Description Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
Period Title: Overall Study
Started 1420
Completed 1420
Not Completed 0
Arm/Group Title CorMatrix ECM
Hide Arm/Group Description Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
Overall Number of Baseline Participants 1,420
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1,420 participants
<=18 years
0
   0.0%
Between 18 and 65 years
845
  59.5%
>=65 years
575
  40.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1,420 participants
61.3  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1,420 participants
Female
376
  26.5%
Male
1,044
  73.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1,420 participants
Hispanic or Latino
118
   8.3%
Not Hispanic or Latino
1,302
  91.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1,420 participants
American Indian or Alaska Native
7
   0.5%
Asian
18
   1.3%
Native Hawaiian or Other Pacific Islander
3
   0.2%
Black or African American
158
  11.1%
White
1,088
  76.6%
More than one race
141
   9.9%
Unknown or Not Reported
5
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1,420 participants
1,420
Pre-Operative Risk Factors  
Measure Type: Number
Unit of measure:  Risk factors
Number Analyzed 1,420 participants
Hypertension 1,138
Hypercholesterolemia 727
Diabetes Mellitus 531
Smoking 357
Prior Myocardial Infarction 242
Congestive Heart Failure 226
Chronic Obstructive Pulmonary Disease 158
Prior Percutaneous Coronary Intervention 126
Chronic Renal Failure 70
Prior Cerebrovascular Accident 60
Index Procedure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1,420 participants
Isolated CABG
923
  65.0%
Valve Repair/Replacement
300
  21.1%
CABG & Valve Repair/Replacement
136
   9.6%
Other
61
   4.3%
1.Primary Outcome
Title Proportion of Subjects With Device Related Adverse Events.
Hide Description Data will be collected at the initial post-operative visit. This is a single visit study.
Time Frame Post-op visit, after an average of 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CorMatrix ECM
Hide Arm/Group Description:
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
Overall Number of Participants Analyzed 1,420
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of subjects
0
(0 to 0)
Time Frame Data was collected through the subjects' first follow-up visit, which ranged from 0 to 229 days post-operatively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CorMatrix ECM
Hide Arm/Group Description Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
All-Cause Mortality
CorMatrix ECM
Affected / at Risk (%)
Total   8/1,420 
Hide Serious Adverse Events
CorMatrix ECM
Affected / at Risk (%)
Total   0/1,420 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CorMatrix ECM
Affected / at Risk (%)
Total   0/1,420 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Director
Organization: Aziyo Biologics, Inc.
Phone: 510-730-7973
EMail: clinical@aziyo.com
Layout table for additonal information
Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT02073331    
Other Study ID Numbers: 14-PR-1095
First Submitted: February 24, 2014
First Posted: February 27, 2014
Results First Submitted: June 26, 2019
Results First Posted: October 4, 2019
Last Update Posted: February 11, 2020