Peripheral Vascular Disease
Conditions
Brief summary
To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.
Detailed description
OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Interventions
DEVICECorMatrix ECM for Vascular Repair
Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.
Sponsors
Elutia Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure 2. Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use 3. Subject possesses ability to provide informed consent 4. Subject expresses understanding and willingness to fulfill all expected requirements of protocol
Exclusion criteria
1\. Known sensitivity to porcine material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-Related Adverse Events | Up to 12 months follow-up | Proportion of patients experiencing device related adverse events. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Observation of subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.
CorMatrix ECM for Vascular Repair: Standard femoral arterial interventional procedure using CorMatrix ECM for arterial repair.
Device performance and adverse events were collected. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Subject refused to return | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 63.7 Years STANDARD_DEVIATION 11 |
| CoMorbidity Risk Factors Active tobacco use | 15 participants |
| CoMorbidity Risk Factors Diabetes | 18 participants |
| CoMorbidity Risk Factors Family Hx of Vascular Disease | 12 participants |
| CoMorbidity Risk Factors Hx of CABG | 10 participants |
| CoMorbidity Risk Factors Hx of renal disease | 7 participants |
| CoMorbidity Risk Factors Hx Sedentary lifestyle | 12 participants |
| CoMorbidity Risk Factors Hyperlipidemia | 26 participants |
| CoMorbidity Risk Factors Hypertension | 35 participants |
| CoMorbidity Risk Factors Obesity | 3 participants |
| CoMorbidity Risk Factors Previous groin surgery | 13 participants |
| CoMorbidity Risk Factors Previous MI | 9 participants |
| CoMorbidity Risk Factors Previous Vascular Surgery | 20 participants |
| Device Performance | 45 Procedures |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Indication for Surgery Acute critical limb ischemia | 7 Surgical Indications |
| Indication for Surgery Claudication (Fontaine class IIb) | 34 Surgical Indications |
| Indication for Surgery Gangrene (Fontaine class IV) | 2 Surgical Indications |
| Indication for Surgery Infected prosthesis | 0 Surgical Indications |
| Indication for Surgery Other | 2 Surgical Indications |
| Indication for Surgery Rest and night pain (Fontaine class III) | 4 Surgical Indications |
| Intervention/Procedure Femoral endarterectomy | 11 Interventions/Procedures |
| Intervention/Procedure Iliofemoral endarterectomy | 30 Interventions/Procedures |
| Intervention/Procedure Iliofemoral endarterectomy with profundaplasty | 3 Interventions/Procedures |
| Intervention/Procedure Other | 1 Interventions/Procedures |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 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 | 29 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 27 Participants |
| Tobacco Use Current smoker | 15 Participants |
| Tobacco Use Never | 5 Participants |
| Tobacco Use Previous smoker | 18 Participants |
| Weight | 177.3 Pounds STANDARD_DEVIATION 37.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 14 / 38 |
Outcome results
Primary
Device-Related Adverse Events
Proportion of patients experiencing device related adverse events.
Time frame: Up to 12 months follow-up
Population: Several participants had both limbs treated resulting in a greater number of procedures than participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Device-Related Adverse Events | 0 Proportion of Participants that Experien |