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

NCT00958230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-11-14

No results posted yet for this study

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

DEVICE

dCell Vascular Patch

Implantation of a dCell Vascular Patch as part of an Endarterectomy

Sponsors & Collaborators

  • Tissue Regenix Ltd

    lead INDUSTRY

Principal Investigators

  • Keith Summerhayes, BSc (Hons) · Tissue Regenix Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2011-11-30

Countries

  • Hungary
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00958230 on ClinicalTrials.gov