Trial Outcomes & Findings for A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction (NCT NCT02418156)
NCT ID: NCT02418156
Last Updated: 2023-07-21
Results Overview
Proportion of patients experiencing device related adverse events.
Recruitment status
COMPLETED
Target enrollment
38 participants
Primary outcome timeframe
Up to 12 months follow-up
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Subject refused to return
|
1
|
Baseline Characteristics
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Baseline characteristics by cohort
| Measure |
Single Arm
n=38 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 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
|
0 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
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 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
|
38 participants
n=5 Participants
|
|
Device Performance
|
45 Procedures
n=5 Participants
|
|
CoMorbidity Risk Factors
Hypertension
|
35 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Hyperlipidemia
|
26 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Diabetes
|
18 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Previous Vascular Surgery
|
20 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Active tobacco use
|
15 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Hx Sedentary lifestyle
|
12 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Family Hx of Vascular Disease
|
12 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Previous groin surgery
|
13 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Hx of CABG
|
10 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Previous MI
|
9 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Hx of renal disease
|
7 participants
n=5 Participants
|
|
CoMorbidity Risk Factors
Obesity
|
3 participants
n=5 Participants
|
|
Weight
|
177.3 Pounds
STANDARD_DEVIATION 37.1 • n=5 Participants
|
|
Tobacco Use
Current smoker
|
15 Participants
n=5 Participants
|
|
Tobacco Use
Previous smoker
|
18 Participants
n=5 Participants
|
|
Tobacco Use
Never
|
5 Participants
n=5 Participants
|
|
Indication for Surgery
Acute critical limb ischemia
|
7 Surgical Indications
n=5 Participants
|
|
Indication for Surgery
Claudication (Fontaine class IIb)
|
34 Surgical Indications
n=5 Participants
|
|
Indication for Surgery
Rest and night pain (Fontaine class III)
|
4 Surgical Indications
n=5 Participants
|
|
Indication for Surgery
Gangrene (Fontaine class IV)
|
2 Surgical Indications
n=5 Participants
|
|
Indication for Surgery
Infected prosthesis
|
0 Surgical Indications
n=5 Participants
|
|
Indication for Surgery
Other
|
2 Surgical Indications
n=5 Participants
|
|
Intervention/Procedure
Iliofemoral endarterectomy
|
30 Interventions/Procedures
n=5 Participants
|
|
Intervention/Procedure
Femoral endarterectomy
|
11 Interventions/Procedures
n=5 Participants
|
|
Intervention/Procedure
Iliofemoral endarterectomy with profundaplasty
|
3 Interventions/Procedures
n=5 Participants
|
|
Intervention/Procedure
Other
|
1 Interventions/Procedures
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months follow-upPopulation: Several participants had both limbs treated resulting in a greater number of procedures than participants analyzed.
Proportion of patients experiencing device related adverse events.
Outcome measures
| Measure |
Single Arm
n=45 Procedures
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-Related Adverse Events
|
0 Proportion of Participants that Experien
Interval 0.0 to 0.0
|
Adverse Events
Single Arm
Serious events: 14 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Single Arm
n=38 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
Depression and Suicide Attempt
|
2.6%
1/38 • Number of events 1 • One year
|
|
Vascular disorders
Non Healing Lower Extremity Ulcer
|
2.6%
1/38 • Number of events 1 • One year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right upper lobe adenocarcinoma
|
2.6%
1/38 • Number of events 1 • One year
|
|
Vascular disorders
Failed Vascular Interventions/Severe PAD
|
2.6%
1/38 • Number of events 1 • One year
|
|
Blood and lymphatic system disorders
Coag Neg Staph Bacteremia
|
2.6%
1/38 • Number of events 1 • One year
|
|
Vascular disorders
Post Operative Seroma
|
2.6%
1/38 • Number of events 1 • One year
|
|
Vascular disorders
Critical Limb Ischemia
|
2.6%
1/38 • Number of events 1 • One year
|
|
Surgical and medical procedures
Pseudoaneurysm
|
2.6%
1/38 • Number of events 1 • One year
|
|
Cardiac disorders
Stroke-like symptoms
|
2.6%
1/38 • Number of events 1 • One year
|
|
Cardiac disorders
Atrial flutter & atrial fibrillation
|
2.6%
1/38 • Number of events 1 • One year
|
|
General disorders
Chest pain
|
2.6%
1/38 • Number of events 1 • One year
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Number of events 1 • One year
|
|
Vascular disorders
Bilaterial lower extremity pain and numbness
|
2.6%
1/38 • Number of events 1 • One year
|
|
Cardiac disorders
CVA
|
2.6%
1/38 • Number of events 1 • One year
|
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