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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Tissue Regenix Ltd.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tissue Regenix Ltd
ClinicalTrials.gov Identifier:
NCT00958230
First received: August 11, 2009
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

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 Intervention
Peripheral Arterial Vascular Occlusion
Device: dCell Vascular Patch

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Tissue Regenix Ltd:

Primary Outcome Measures:
  • Maintenance of Arterial Patency [ Time Frame: 6 months for CE Mark, 24 months Post Market Surveillance ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication Rate [ Time Frame: 6 months for CE Mark, 24 months for PMS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: October 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958230

Locations
Hungary
Szent Imre Hospital
Budapest, Hungary, H-1115
Miskolc Hospital
Miskolc, Hungary, H-3501
Semmelweis University Hospital
Semmelweis, Hungary, H-1122
Netherlands
Saint Elisabeth Hospital
Otrobanda, Curacao, Netherlands
Sponsors and Collaborators
Tissue Regenix Ltd
Investigators
Study Director: Keith Summerhayes, BSc (Hons) Tissue Regenix Ltd
  More Information

No publications provided

Responsible Party: Keith Summerhayes, Manager Clinical Affairs, Sponsor - Tissue Regenix Ltd
ClinicalTrials.gov Identifier: NCT00958230     History of Changes
Other Study ID Numbers: TRL P001-09
Study First Received: August 11, 2009
Last Updated: September 9, 2010
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Tissue Regenix Ltd:
endarterectomy
dCell
Tissue Regenix Ltd
TRL
Vascular Patch
Treatment

ClinicalTrials.gov processed this record on July 24, 2014