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To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorMatrix ECM for Vascular Repair | Device | Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device-Related Adverse Events | Proportion of patients experiencing device related adverse events. | Up to 12 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
1. Known sensitivity to porcine material
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Patients presenting for femoral arterial reconstruction with patch angioplasty.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Device-Related Adverse Events | Proportion of patients experiencing device related adverse events. | Several participants had both limbs treated resulting in a greater number of procedures than participants analyzed. | Posted | Number | 95% Confidence Interval | Proportion of Participants that Experien | Up to 12 months follow-up | Procedures | Procedures |
|
|
One year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression and Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Aziyo Biolgics, Inc. | 470-514-4085 | clinical@aziyo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2016 | Jan 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Withdrawal by Subject |
|
| Subject refused to return |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Device Performance | Number | Procedures |
|
| CoMorbidity Risk Factors | Number | participants |
|
| Weight | Mean | Standard Deviation | Pounds |
|
| Tobacco Use | Count of Participants | Participants |
|
| Indication for Surgery | Number | Surgical Indications |
|
| Intervention/Procedure | Number | Interventions/Procedures |
|
| Participants |
|
| Procedures |
|
|
| 2 |
| 38 |
| 14 |
| 38 |
| 0 |
| 38 |
| Non Healing Lower Extremity Ulcer | Vascular disorders | Non-systematic Assessment |
|
| Right upper lobe adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Failed Vascular Interventions/Severe PAD | Vascular disorders | Non-systematic Assessment |
|
| Coag Neg Staph Bacteremia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Post Operative Seroma | Vascular disorders | Non-systematic Assessment |
|
| Critical Limb Ischemia | Vascular disorders | Non-systematic Assessment |
|
| Pseudoaneurysm | Surgical and medical procedures | Non-systematic Assessment | Due to a broken suture along the medial line of anastomosis. |
|
| Stroke-like symptoms | Cardiac disorders | Non-systematic Assessment |
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| Atrial flutter & atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bilaterial lower extremity pain and numbness | Vascular disorders | Non-systematic Assessment |
|
| CVA | Cardiac disorders | Non-systematic Assessment |
|
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