NCT00958230

dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission

An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Tissue Regenix Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Vascular Occlusion

Interventions

Type	Name	Description
DEVICE	dCell Vascular Patch	Implantation of a dCell Vascular Patch as part of an Endarterectomy

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-04-01
• Completion: 2011-11-01
• First posted: 2009-08-13
• Last updated: 2014-11-14

Locations

4 sites across 2 countries: Hungary, Netherlands