Carotid Stenosis
Conditions
Brief summary
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
Detailed description
The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.
Interventions
DEVICECorMatrix ECM for Carotid Repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
Sponsors
Elutia Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects must be undergoing carotid endarterectomy with patch angioplasty closure. * Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use. * The subject must possess the ability to provide written Informed Consent. * The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol.
Exclusion criteria
* Subjects with a known sensitivity to porcine material.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid Procedure and Device Related Adverse Events to Determine Device Performance | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carotid Endarterectomy Subjects CorMatrix ECM for Carotid Repair: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure | 221 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 13 |
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | No ECM used | 9 |
| Overall Study | Other | 4 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Carotid Endarterectomy Subjects |
|---|---|
| Age, Continuous | 69.9 Years STANDARD_DEVIATION 10 |
| Co-Morbidity Risk Factors CHF | 19 Participants |
| Co-Morbidity Risk Factors Chronic Renal Failure | 19 Participants |
| Co-Morbidity Risk Factors COPD | 32 Participants |
| Co-Morbidity Risk Factors Diabetes | 84 Participants |
| Co-Morbidity Risk Factors Hypertension | 182 Participants |
| Co-Morbidity Risk Factors Obesity | 47 Participants |
| Co-Morbidity Risk Factors Previous AF | 22 Participants |
| Co-Morbidity Risk Factors Previous MI | 45 Participants |
| Co-Morbidity Risk Factors Previous Neck Radiation | 2 Participants |
| Co-Morbidity Risk Factors Previous Neck Surgery | 34 Participants |
| Co-Morbidity Risk Factors Previous Stroke | 43 Participants |
| Co-Morbidity Risk Factors Previous Stroke - Symptomatic | 20 Participants |
| Co-Morbidity Risk Factors Previous TIA | 51 Participants |
| Co-Morbidity Risk Factors Previous TIA - Symptomatic | 22 Participants |
| Co-Morbidity Risk Factors Smoking | 75 Participants |
| Co-Morbidity Risk Factors Valve Disease | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 221 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 203 Participants |
| Region of Enrollment United States | 221 participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 221 |
| other Total, other adverse events | 0 / 221 |
| serious Total, serious adverse events | 25 / 221 |
Outcome results
Primary
Carotid Procedure and Device Related Adverse Events to Determine Device Performance
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carotid Endarterectomy Subjects | Carotid Procedure and Device Related Adverse Events to Determine Device Performance | Not related to device | 53 Device related adverse events |
| Carotid Endarterectomy Subjects | Carotid Procedure and Device Related Adverse Events to Determine Device Performance | Possibly related to device | 10 Device related adverse events |
| Carotid Endarterectomy Subjects | Carotid Procedure and Device Related Adverse Events to Determine Device Performance | Probably related to device | 1 Device related adverse events |
| Carotid Endarterectomy Subjects | Carotid Procedure and Device Related Adverse Events to Determine Device Performance | Definitely related to device | 2 Device related adverse events |