dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery|
- Maintenance of Arterial Patency [ Time Frame: 6 months for CE Mark, 24 months Post Market Surveillance ] [ Designated as safety issue: No ]
- Complication Rate [ Time Frame: 6 months for CE Mark, 24 months for PMS ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: dCell Vascular Patch
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.
Device: dCell Vascular Patch
Implantation of a dCell Vascular Patch as part of an Endarterectomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958230
|Szent Imre Hospital|
|Budapest, Hungary, H-1115|
|Miskolc, Hungary, H-3501|
|Semmelweis University Hospital|
|Semmelweis, Hungary, H-1122|
|Saint Elisabeth Hospital|
|Otrobanda, Curacao, Netherlands|
|Study Director:||Keith Summerhayes, BSc (Hons)||Tissue Regenix Ltd|