Trial Outcomes & Findings for Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix) (NCT NCT02073331)
NCT ID: NCT02073331
Last Updated: 2023-07-21
Results Overview
Data will be collected at the initial post-operative visit. This is a single visit study.
Recruitment status
COMPLETED
Target enrollment
1420 participants
Primary outcome timeframe
Post-op visit, after an average of 30 days
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
CorMatrix ECM
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
|
|---|---|
|
Overall Study
STARTED
|
1420
|
|
Overall Study
COMPLETED
|
1420
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
Baseline characteristics by cohort
| Measure |
CorMatrix ECM
n=1 Participants
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
845 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
575 Participants
n=5 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
376 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1,044 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1,302 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1,088 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1,420 participants
n=5 Participants
|
|
Pre-Operative Risk Factors
Hypertension
|
1,138 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Hypercholesterolemia
|
727 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Diabetes Mellitus
|
531 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Smoking
|
357 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Prior Myocardial Infarction
|
242 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Congestive Heart Failure
|
226 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Chronic Obstructive Pulmonary Disease
|
158 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Prior Percutaneous Coronary Intervention
|
126 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Chronic Renal Failure
|
70 Risk factors
n=5 Participants
|
|
Pre-Operative Risk Factors
Prior Cerebrovascular Accident
|
60 Risk factors
n=5 Participants
|
|
Index Procedure
Isolated CABG
|
923 Participants
n=5 Participants
|
|
Index Procedure
Valve Repair/Replacement
|
300 Participants
n=5 Participants
|
|
Index Procedure
CABG & Valve Repair/Replacement
|
136 Participants
n=5 Participants
|
|
Index Procedure
Other
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-op visit, after an average of 30 daysData will be collected at the initial post-operative visit. This is a single visit study.
Outcome measures
| Measure |
CorMatrix ECM
n=1 Participants
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
|
|---|---|
|
Proportion of Subjects With Device Related Adverse Events.
|
0 Proportion of subjects
Interval 0.0 to 0.0
|
Adverse Events
CorMatrix ECM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60