dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00958230|
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : November 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Vascular Occlusion||Device: dCell Vascular Patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||November 2011|
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
- Maintenance of Arterial Patency [ Time Frame: 6 months for CE Mark, 24 months Post Market Surveillance ]
- Complication Rate [ Time Frame: 6 months for CE Mark, 24 months for PMS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|