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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. Identifier: NCT00958230
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : November 14, 2014
Information provided by (Responsible Party):
Tissue Regenix Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Vascular Occlusion Device: dCell Vascular Patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : November 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Maintenance of Arterial Patency [ Time Frame: 6 months for CE Mark, 24 months Post Market Surveillance ]

Secondary Outcome Measures :
  1. Complication Rate [ Time Frame: 6 months for CE Mark, 24 months for PMS ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients scheduled for a remote or open peripheral vascular endarterectomy
  2. Lack of suitable autologous material to function as closure patch for the arteriotomy
  3. Uncomplicated standard elective endarterectomy procedure (per-operative inclusion criteria)
  4. Use of dCell™ Vascular Patch as arteriotomy closure material (per-operative inclusion criteria)
  5. Patients between 18 and 80 years old, inclusive
  6. Haemoglobin > 9 g/dL and platelet count > 100,000/mm3 prior to Day 1
  7. Other haematological and biochemical parameters within a range acceptable for the administration of general anesthesia prior to Day 1
  8. Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
  9. Duly executed, written, informed consent obtained from patient

Exclusion Criteria:

  1. Known serious allergy to contrast agent used for angiography
  2. Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
  3. If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
  4. Patients receiving a revision of an existing graft
  5. Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3)
  6. Any condition which in the judgment of the Investigator would preclude adequate evaluation of dCell™ Vascular Patch's safety and performance
  7. Patients on vitamin K antagonists

Information from the National Library of Medicine

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 identifier (NCT number): NCT00958230

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Szent Imre Hospital
Budapest, Hungary, H-1115
Miskolc Hospital
Miskolc, Hungary, H-3501
Semmelweis University Hospital
Semmelweis, Hungary, H-1122
Saint Elisabeth Hospital
Otrobanda, Curacao, Netherlands
Sponsors and Collaborators
Tissue Regenix Ltd
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Study Director: Keith Summerhayes, BSc (Hons) Tissue Regenix Ltd
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Responsible Party: Tissue Regenix Ltd Identifier: NCT00958230    
Other Study ID Numbers: TRL P001-09
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: September 2010
Keywords provided by Tissue Regenix Ltd:
Tissue Regenix Ltd
Vascular Patch