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Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid Endarterectomy Subjects | Subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorMatrix ECM for Carotid Repair | Device | Subjects must be undergoing carotid endarterectomy with patch angioplasty closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid Procedure and Device Related Adverse Events to Determine Device Performance | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 230 subjects may be enrolled from up to ten U.S. clinical sites
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardio-Thoracic Surgeons, P.C. Trinity | Birmingham | Alabama | 35243 | United States | ||
| Vascular Surgical Associates P.C. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carotid Endarterectomy Subjects | CorMatrix ECM for Carotid Repair: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Carotid Procedure and Device Related Adverse Events to Determine Device Performance | Posted | Number | Device related adverse events | 2 years |
|
|
2 years
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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 | Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI bleed | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Aziyo Biolgics, Inc. | 510-730-7973 | 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 | Feb 16, 2018 | Feb 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Marietta |
| Georgia |
| 30060 |
| United States |
| Cardiac Surgery Associates | Indianapolis | Indiana | 46237 | United States |
| St Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Cardiovascular Surgery Clinic, PLLC | Memphis | Tennessee | 38120 | United States |
| UVA Heart and Vascular Center | Charlottesville | Virginia | 22908 | United States |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Other |
|
| No ECM used |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Co-Morbidity Risk Factors | Count of Participants | Participants |
|
|
| 13 |
| 221 |
| 25 |
| 221 |
| 0 |
| 221 |
| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| CVA | Cardiac disorders | Non-systematic Assessment |
|
| Blown carotid patch | Product Issues | Non-systematic Assessment |
|
| Orthostatic hypotension episodes | Cardiac disorders | Non-systematic Assessment |
|
| Post-op hoarseness from intubation | Surgical and medical procedures | Non-systematic Assessment |
|
| Migraine | General disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Herald Bleed | Product Issues | Non-systematic Assessment |
|
| VATS | Surgical and medical procedures | Non-systematic Assessment |
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| Restenosis | Cardiac disorders | Non-systematic Assessment |
|
| Superficial wound dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Elective CABG | Cardiac disorders | Non-systematic Assessment |
|
| Neck abcess | Infections and infestations | Non-systematic Assessment |
|
| Disarthria/TIA | Cardiac disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |