Trial Outcomes & Findings for CorMatrix ECM for Carotid Repair Following Endarterectomy Registry (NCT NCT01569594)

NCT ID: NCT01569594

Last Updated: 2023-07-21

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 230 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2023-07-21

Participant Flow

Participant milestones

Measure	Single Arm Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material.
Overall Study STARTED	230
Overall Study COMPLETED	163
Overall Study NOT COMPLETED	67

Reasons for withdrawal

Measure	Single Arm Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material.
Overall Study Physician Decision	4
Overall Study Death	13
Overall Study Lost to Follow-up	22
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	13
Overall Study Other	4
Overall Study No ECM used	9

Baseline Characteristics

CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

Baseline characteristics by cohort

Measure	Carotid Endarterectomy Subjects n=221 Participants CorMatrix ECM for Carotid Repair: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
Age, Continuous	69.9 Years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	203 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	221 participants n=5 Participants
Co-Morbidity Risk Factors Hypertension	182 Participants n=5 Participants
Co-Morbidity Risk Factors COPD	32 Participants n=5 Participants
Co-Morbidity Risk Factors Diabetes	84 Participants n=5 Participants
Co-Morbidity Risk Factors Chronic Renal Failure	19 Participants n=5 Participants
Co-Morbidity Risk Factors CHF	19 Participants n=5 Participants
Co-Morbidity Risk Factors Valve Disease	9 Participants n=5 Participants
Co-Morbidity Risk Factors Previous AF	22 Participants n=5 Participants
Co-Morbidity Risk Factors Previous MI	45 Participants n=5 Participants
Co-Morbidity Risk Factors Previous TIA	51 Participants n=5 Participants
Co-Morbidity Risk Factors Previous TIA - Symptomatic	22 Participants n=5 Participants
Co-Morbidity Risk Factors Previous Stroke	43 Participants n=5 Participants
Co-Morbidity Risk Factors Previous Stroke - Symptomatic	20 Participants n=5 Participants
Co-Morbidity Risk Factors Obesity	47 Participants n=5 Participants
Co-Morbidity Risk Factors Smoking	75 Participants n=5 Participants
Co-Morbidity Risk Factors Previous Neck Surgery	34 Participants n=5 Participants
Co-Morbidity Risk Factors Previous Neck Radiation	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Carotid Endarterectomy Subjects n=221 Participants CorMatrix ECM for Carotid Repair: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
Carotid Procedure and Device Related Adverse Events to Determine Device Performance Not related to device	53 Device related adverse events
Carotid Procedure and Device Related Adverse Events to Determine Device Performance Possibly related to device	10 Device related adverse events
Carotid Procedure and Device Related Adverse Events to Determine Device Performance Probably related to device	1 Device related adverse events
Carotid Procedure and Device Related Adverse Events to Determine Device Performance Definitely related to device	2 Device related adverse events

Adverse Events

Single Arm

Serious events: 25 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Measure	Single Arm n=221 participants at risk Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material.
Gastrointestinal disorders GI bleed	0.45% 1/221 • Number of events 1 • 2 years
Blood and lymphatic system disorders Hematoma	1.8% 4/221 • Number of events 4 • 2 years
Cardiac disorders CVA	2.3% 5/221 • Number of events 5 • 2 years
Product Issues Blown carotid patch	0.45% 1/221 • Number of events 1 • 2 years
Cardiac disorders Orthostatic hypotension episodes	0.45% 1/221 • Number of events 1 • 2 years
Surgical and medical procedures Post-op hoarseness from intubation	0.45% 1/221 • Number of events 1 • 2 years
General disorders Migraine	0.45% 1/221 • Number of events 1 • 2 years
Cardiac disorders Myocardial infarction	0.90% 2/221 • Number of events 2 • 2 years
Product Issues Herald Bleed	0.45% 1/221 • Number of events 1 • 2 years
Surgical and medical procedures VATS	0.45% 1/221 • Number of events 1 • 2 years
Cardiac disorders Restenosis	1.4% 3/221 • Number of events 3 • 2 years
Skin and subcutaneous tissue disorders Superficial wound dehiscence	0.45% 1/221 • Number of events 1 • 2 years
Cardiac disorders Elective CABG	0.45% 1/221 • Number of events 1 • 2 years
Infections and infestations Neck abcess	0.45% 1/221 • Number of events 1 • 2 years
Cardiac disorders Disarthria/TIA	0.45% 1/221 • Number of events 1 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Clinical Director

Aziyo Biolgics, Inc.

Phone: 510-730-7973

Email: clinical@aziyo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place