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The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair the incision after removal of an atherosclerotic plaque that was stopping usual blood flow to the limbs).
Data is being collected to show the procedure is safe and allows for normal blood flow to be resumed.
Data will be used to facilitate CE Mark submission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dCell Vascular Patch | Experimental | This Xenograft device is manufactured from Porcine Pericardium Tissue which has been decellularised leaving a scaffold style structure for ingrowth of human endothelial cells after placement into the operative site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dCell Vascular Patch | Device | Implantation of a dCell Vascular Patch as part of an Endarterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Arterial Patency | 6 months for CE Mark, 24 months Post Market Surveillance |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | 6 months for CE Mark, 24 months for PMS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Summerhayes, BSc (Hons) | Tissue Regenix Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szent Imre Hospital | Budapest | H-1115 | Hungary | |||
| Miskolc Hospital |
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| Miskolc |
| H-3501 |
| Hungary |
| Semmelweis University Hospital | Semmelweis | H-1122 | Hungary |
| Saint Elisabeth Hospital | Otrobanda | Curacao | Netherlands |