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

Tracking Information
First Submitted Date  ICMJE August 11, 2009
First Posted Date  ICMJE August 13, 2009
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2009)
Maintenance of Arterial Patency [ Time Frame: 6 months for CE Mark, 24 months Post Market Surveillance ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2009)
Complication Rate [ Time Frame: 6 months for CE Mark, 24 months for PMS ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
Official Title  ICMJE An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Vascular Occlusion
Intervention  ICMJE Device: dCell Vascular Patch
Implantation of a dCell Vascular Patch as part of an Endarterectomy
Study Arms  ICMJE 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.
Intervention: Device: dCell Vascular Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2009)
20
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00958230
Other Study ID Numbers  ICMJE TRL P001-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tissue Regenix Ltd
Study Sponsor  ICMJE Tissue Regenix Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Keith Summerhayes, BSc (Hons) Tissue Regenix Ltd
PRS Account Tissue Regenix Ltd
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP