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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Vascular Occlusion
• Intervention / Treatment: Device: dCell Vascular Patch

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, H-1115
    • Szent Imre Hospital
  • Miskolc, Hungary, H-3501
    • Miskolc Hospital
  • Semmelweis, Hungary, H-1122
    • Semmelweis University Hospital
• Netherlands
  • Curacao
    • Otrobanda, Curacao, Netherlands
      • Saint Elisabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maintenance of Arterial Patency	6 months for CE Mark, 24 months Post Market Surveillance

Secondary Outcome Measures

Outcome Measure	Time Frame
Complication Rate	6 months for CE Mark, 24 months for PMS

Collaborators and Investigators

• Sponsor: Tissue Regenix Ltd
• Investigators: Study Director: Keith Summerhayes, BSc (Hons), Tissue Regenix Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Treatment; endarterectomy; TRL; dCell; Tissue Regenix Ltd; Vascular Patch
• Other Study ID Numbers: TRL P001-09